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1183 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Kerendia (finerenone) / Bayer
2021-001661-21: Feasibility of aggressively lowering urine albumin in individuals with kidney biopsy-proven diabetic kidney disease - A Pilot Study

Not yet recruiting
4
20
Europe
Tablet, Injection, Forxiga, Jardiance, Ozempic, Telmisartan, Losartan, hydrochlorthiazide, Spironolactone, Trental, Olumiant, Kerendia, Rybelsus
Herlev and Gentofte Hospital, Herlev and Gentofte Hospital
Diabetic Kidney Disease, Kidney Disease due to diabetes mellitus type 2, Diseases [C] - Hormonal diseases [C19]
 
 
NCT05924620: Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Completed
4
60
RoW
finerenone, Kerendia
Chongqing Medical University
Primary Aldosteronism
03/24
03/24
FAVOR, NCT06164379: Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

Not yet recruiting
4
150
RoW
Finerenone, Spironolactone
Shanghai Jiao Tong University School of Medicine
Primary Aldosteronism
12/24
12/24
NCT06381323: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Recruiting
4
55
RoW
Finerenone, Nifedipine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Primary Aldosteronism, Finerenone, Mineralocorticoid Receptor Antagonist
03/27
04/27
NCT06457074: Finerenone for Patients With Primary Aldosteronism (FAIRY)

Recruiting
4
306
RoW
Finerenone Oral Tablet, Finerenone, Spironolactone Oral Tablet, Spironolactone
Qifu Li, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Changzhi Medical College
Primary Aldosteronism
06/25
06/26
Optimize@Home, NCT06094920: Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial

Enrolling by invitation
4
10
Europe
Empagliflozin 10 MG, Jardiance, A10BK03, (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol, Finerenone, Kerendia, C03DA05, (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide, Withings BPM Connect, Withings Body, PeeSpot Urine Collection Device, Hem-Col Capillary Blood Collection Device, Questionnaire: participants' perspectives toward the feasibility of participation in a trial at home with digital technologies
University Medical Center Groningen, Boehringer Ingelheim
Diabetes Mellitus Type 2 With Proteinuria, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetes, Diabetes Complications, Albuminuria, Chronic Kidney Diseases, Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, CKD, CKD Stage 3, CKD Stage 4
10/24
11/24
NCT06573411: Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Not yet recruiting
4
88
NA
ACEI/ARB+ finerenone, ACEI/ARB+ Placebo
First Affiliated Hospital, Sun Yat-Sen University
Primary Membranous Nephropathy
10/25
10/25
RAiSiN, NCT06727409: Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i As Triple Therapy with Type 2 Diabetes and Chronic Kidney Disease

Recruiting
4
82
RoW
Finerenone
Chinese University of Hong Kong
Patients with Type 2 Diabetes
07/26
12/26
FIVE-STAR, NCT05887817: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD

Active, not recruiting
4
100
Japan
Finerenone, Kerendia, Placebo
Saga University
Type 2 Diabetes, Chronic Kidney Diseases
02/25
07/26
NCT05814770: Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Not yet recruiting
4
96
NA
Finerenone, Kerendia, Spironolactone
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, National Key Research and Development Program of China, National Natural Science Foundation of China
Primary Aldosteronism, Hypertension
03/25
03/26
ChiCTR2300078226: Efficacy and safety of initial treatment of Finerenone combined with Henagliflozein in patients with type 2 diabetes with microalbuminuria: a randomized, parallel, controlled, three-arm clinical study

Recruiting
4
300
 
Losartan 50mg qd combined with Henagliflozein 5mg qd; Losartan 50mg qd combined with Finerenone 10mg qd; Losartan 50mg qd in combination with Finerenone 10mg qd and Henagliflozein 5mg qd
Peking University First Hospital; Peking University First Hospital, self-funded
Type 2 diabetes
 
 
ChiCTR2400086830: Mechanism study of finerenone in the treatment of diabetic kidney disease

Not yet recruiting
4
300
 
finerenone treatment; ACEI or ARB; None
The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Zhengzhou University
diabetic kidney disease
 
 
NCT05705271: A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus

Active, not recruiting
4
200
RoW
Finerenone (Kerendia, BAY94-8862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
07/25
07/25
ChiCTR2300069660: Compare the Efficacy and Safety of Finerenone, a New Type of Mineralocorticoid Receptor Antagonist, and Spironolactone in the Treatment of Primary Aldosteronism: a Single-Center, Prospective, Randomized Controlled Study

Not yet recruiting
4
96
 
Finerenone ;Spironolactone
Drum Tower Hospital Affiliated to Nanjing University Medical School; Drum Tower Hospital Affiliated to Nanjing University Medical School, National Key Research and Development Program of China (2021YFC2501600, 2021YFC2501603)
Primary Aldosteronism
 
 
EMRACVDHHA, NCT05688579: Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia

Enrolling by invitation
4
8000
RoW
Mineralocorticoid Receptor Antagonists(MRAs), Blank control, Placebo
Nanfang Li
Hypertension, Hyperaldosteronaemia
12/26
12/26
2015-002168-17: Efficacy and safety of finerenone in subjects with chronic heart failure at high risk of recurrent heart failure decompensation

Ongoing
3
5890
Europe, RoW
BAY 94-8862 IR tablet 10 mg, BAY 94-8862 IR tablet 20 mg, Eplerenone 25 mg Film-coated Tablets, Eplerenone 50 mg Film-coated Tablets, BAY 94-8862 coated tablet 10 mg, BAY 94-8862 coated tablet 20 mg, Film-coated tablet, Eplerenone 25 mg Film-coated Tablets, Eplerenone 50 mg Film-coated Tablets
Bayer HealthCare AG, Bayer HealthCare AG
Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both, CHF (reduction of the pumping capacity of the heart), DM type 2 (body's ineffective use of insulin) and CKD (kidneys fail to adequately filter toxins and waste products from the blood), Diseases [C] - Cardiovascular Diseases [C14]
 
 
NCT06244758: Finerenone and Renal Oxidative Stress

Recruiting
3
75
Europe
Finerenone 20 MG Oral Tablet, Placebo
University of Erlangen-Nürnberg Medical School, Bayer
Type2diabetes
06/25
12/25
FINEARTS-HF, NCT04435626 / 2020-000306-29: Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

Completed
3
6016
Europe, Canada, Japan, US, RoW
Finerenone (BAY94-8862), Placebo
Bayer
Heart Failure
05/24
06/24
FIGHT, NCT06580288: Effect of Finerenone in IgA Nephropathy

Not yet recruiting
3
120
NA
Finerenone, Placebo
Zhejiang University
IgA Nephropathy
06/26
10/26
CONFIRMATION, NCT06024746: A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (-HF)

Recruiting
3
1500
Canada, US, RoW
Finerenone, Empagliflozin
Colorado Prevention Center, Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Heart Failure
07/26
08/26
FINE-ONE, NCT05901831: A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes

Active, not recruiting
3
220
Europe, Canada, US, RoW
Finerenone, Placebo
Bayer
Chronic Kidney Disease, Type 1 Diabetes Mellitus
08/25
09/25
FIND-CKD, NCT05047263 / 2021-000421-27: A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

Active, not recruiting
3
1584
Europe, Japan, US, RoW
Finerenone (BAY94-8862), Placebo
Bayer
Non-diabetic Chronic Kidney Disease
01/26
02/26
REDEFINE-HF, NCT06008197: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Recruiting
3
5200
US
Finerenone, Kerendia, Placebo
Colorado Prevention Center, Saint Luke's Hospital of Kansas City, Bayer
Heart Failure, Acute Heart Failure
04/26
04/26
FINALITY-HF, NCT06033950: A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

Recruiting
3
2600
Canada, US, RoW
Finerenone, Placebo
Colorado Prevention Center, St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Heart Failure
03/28
04/28
FIONA, NCT05196035 / 2021-002071-19: A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Recruiting
3
219
Europe, Canada, US, RoW
Finerenone (Kerendia, BAY94-8862), Placebo
Bayer
Chronic Kidney Disease, Proteinuria
07/27
08/27
CAPTIVATE, NCT06058585: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Recruiting
3
1000
RoW
Finerenone, BAY94-8862, Placebo Finerenone
The George Institute
Chronic Kidney Diseases
08/28
12/28
FIONA OLE, NCT05457283 / 2021-002905-89: A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Recruiting
3
100
Europe, Canada, US, RoW
Finerenone (Kerendia, BAY94-8862)
Bayer, Bayer AG
Chronic Kidney Disease, Proteinuria, Children
01/29
02/29
Steno1, NCT06082063: Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Recruiting
3
2000
Europe
Aspirin tablet, Semaglutide, Sotagliflozin, Finerenone
Steno Diabetes Center Copenhagen, Aarhus University Hospital, Steno Diabetes Center Nordjylland, Steno Diabetes Center Odense, Slagelse Hospital, Nykøbing Falster County Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Herning Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Regionshospitalet Silkeborg, Bispebjerg Hospital, Regionshospitalet Horsens
Cardiovascular Diseases, Heart Failure, Type 1 Diabetes, Kidney Failure
07/29
07/29
2020-003865-20: A study that uses data from routine eye examinations of patients participating in studies FIDELIO-DKD and FIGARO-DKD to explore whether Finerenone can delay the progression of a diabetes complication that affects the eyes (diabetic retinopathy ,DR)

Not yet recruiting
2
90
Europe
Finerenone, BAY 94-8862 IR tablet 10 mg, Film-coated tablet
Bayer AG, Bayer AG
Diabetic Retinopathy, An eye condition called diabetic retinopathy (DR) that affects people with diabetes. People with DR have damage to the blood vessels in the tissue at the back of the eye called the retina., Diseases [C] - Cardiovascular Diseases [C14]
 
 
CONFIDENCE, NCT05254002 / 2021-003037-11: A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

Completed
2
1664
Europe, Canada, Japan, US, RoW
Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
Bayer
Type 2 Diabetes Mellitus, Chronic Kidney Disease
03/25
03/25
EFFEKTOR, NCT06059664: The EFfect of FinErenone in Kidney TransplantiOn Recipients: The Study

Recruiting
2
150
US
Finerenone Oral Tablet, Kerendia, Placebo, Sugar pill
University of North Carolina, Chapel Hill, Bayer
Kidney Transplant; Complications
02/25
05/26
EmFin-Nx, NCT06818305: Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: a Multicenter RCT

Recruiting
2
100
RoW
Finerenone (BAY 94-8862), Empagliflozin 10 mg
Jinling Hospital, China, The Affiliated Hospital of Xuzhou Medical University, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, The First Affiliated Hospital with Nanjing Medical University
Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Nephrectomy, Chronic Kidney Disease(CKD)
01/27
12/27
NCT06835322: Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Recruiting
2
100
RoW
Finerenone, Placebo
Alexandria University
Glomerulonephritis
08/25
09/25
FibroCAN, NCT06906081: Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the Study

Not yet recruiting
2
100
Europe
Kerendia (Finerenone, BAY94-8862), Placebo
Peter Rossing, Steno Diabetes Center Nordjylland, Aarhus University Hospital
Cardiovascular Autonomic Neuropathy, Type 2 Diabetes, Diabetic Neuropathies
11/27
11/27
WP3, NCT05897372: Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study

Terminated
2
1
Europe
ACEi / ARB, SGLT2i, finerenone, semaglutide, pentoxifylline, hydrochlorthiazide, baricitinib
Iain Bressendorff
Diabetic Kidney Disease
09/24
09/24
PolyPreventHF, NCT06143566: Polypill for Prevention of Cardiomyopathy

Recruiting
1/2
60
US
Polypill, (Finerenone, Empagliflozin, Losartan)
University of Texas Southwestern Medical Center
Type 2 Diabetes, High Blood Pressure
09/25
12/25
ChiCTR2400079455: A multicenter, randomized, double-blind, crossover controlled clinical study of the treatment of Alport syndrome with Henagliflozin, Finerenone, and combination therapy.

Recruiting
1
60
 
Henagliflozin: In the first cycle (from day 1 to day 60), patients assigned to the SGLT2i group were required to take the corresponding medication for one month (SGLT2i group: Henagliflozin 10mg qd + 1 tablet of Finerenone placebo), followed by one month of placebo washout (2 placebos, including 1 SGLT2 placebo + 1 MRA placebo). In the second cycle (from day 61 to day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug treatment from the first cycle (one subgroup received MRA + SGLT2i placebo, and the other subgroup received SGLT2i + MRA). In the third cycle (from day 121 to day 180): each group of patients received a different drug treatment plan from the first and second cycles for one month, followed by one month of placebo washout.; Finerenone: The first cycle (from day 1 to day 60) involved patients randomly assigned to the MRA group who were required to take the corresponding medication for one month (MRA group: Finerenone 10mg qd + 1 tablet of Henagliflozin placebo), followed by one month of placebo washout. In the second cycle (from day 61 to day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug treatment from the first cycle (one subgroup received SGLT2i + MRA placebo, and the other subgroup received SGLT2i + MRA). In the third cycle (from day 121 to day 180): each group of patients received a different drug treatment plan from the first and second cycles for one month, followed by one month of placebo washout; Henagliflozin+Finerenone: The first cycle (Day 1 to Day 60) involved the random allocation of patients to the combination therapy group, where they were required to take the corresponding medication for one month (combination therapy group: empagliflozin 10mg qd + finerenone 10mg qd), followed by one month of placebo. In the second cycle (Day 61 to Day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug regimen from the first cycle (one subgroup received SGLT2i + MRA placebo, and the other subgroup received SGLT2i placebo + MRA). The third cycle (Day 121 to Day 180) involved each group of patients receiving a different drug treatment plan from both the first and second cycles for one month, followed by one month of placebo washout.
peking university first hospital; peking university first hospital, Undertaking by the investigator
Alport syndrome
 
 
NCT02378805: Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome

Recruiting
N/A
800
Europe
ACE-inhibitor, Angiotensin-receptor blocker (ARB), HMG-Coenzyme inhibitor (statin), Spironolactone or Finerenone, Paricalcitol, SGLT2 inhibitor
University Hospital Goettingen, Society for Pediatric Nephrology (Germany)
Alport Syndrome, Hereditary Kidney Disease, Pediatric Kidney Disease, Thin Basement Membrane Disease, Familial Benign Hematuria
03/36
03/36
NCT06460987: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

Completed
N/A
245
RoW
Finerenone, FINE, RAS inhibitor, RASI, Immune Suppressant, immunosupressive
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Finerenone, IgA Nephropathy, Proteinuria, Safety Issues
03/24
03/24
NCT06301022: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus

Recruiting
N/A
90
RoW
First Affiliated Hospital of Harbin Medical University
Chronic Kidney Diseases
10/24
12/24
NCT05974566: Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction

Not yet recruiting
N/A
60
NA
Chongqing Medical University
Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Diabetic Nephropathies
09/23
10/23
FLAMINGO, NCT05640180: An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results

Completed
N/A
17847
US
Finerenone (Kerendia, BAY94-8862), Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
Bayer
Chronic Kidney Disease, Type 2 Diabetes
12/23
12/23
KSD-01, NCT06838416: Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

Recruiting
N/A
300
RoW
Finerenone, Angiotensin II Receptor Blockers
Second Affiliated Hospital of Soochow University
Type 2 Diabetes Mellitus, Chronic Kidney Disease, Renal Function
12/25
12/26
FIRST-2, NCT05703880: An Observational Study Called .0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Completed
N/A
15948
US
Finerenone (Kerendia, BAY948862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/24
10/24
FINEROD, NCT06278207: An Observational Study Called to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Recruiting
N/A
50000
Europe, Japan, US
Finerenone (BAY 94-8862), Kerendia, Firialta
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/25
10/25
FINEGUST, NCT05526157: An Observational Study, Called , to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice

Completed
N/A
50000
Europe, Japan, US
Finerenone (Kerendia, BAY 948862), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Steroidal mineral corticoid receptor antagonists (sMRA), Non-steroidal mineral corticoid receptor antagonists (nsMRA)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
09/24
09/24
NCT06608212: An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States

Active, not recruiting
N/A
150000
US
Finerenone (Kerendia, BAY948862), Others except finerenone
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
06/25
06/25
ChiCTR2400087169: Efficacy and safety of Finerenone in patients with type 2 diabetes mellitus combined with chronic kidney disease in a "in person-remote" diabetes mellitus self-management support model: a single-center retrospective real-world study

Not yet recruiting
N/A
1420
 
Continuous application of Finerenone for at least 3 months at the Diabetes Shared Care Real World Management Follow-Up; CKD adjudicated at the Diabetes Shared Care Real World Management Follow-Up, but not clinically applied Finerenone
Peking University First Hospital; Peking University First Hospital, self-funded
Type 2 Diabetes Mellitus
 
 
IN-REALITY, NCT06763146: An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice

Not yet recruiting
N/A
1200
RoW
Finerenone (Kerendia, BAY948862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/25
10/25
ChiCTR2400090272: An open-label, single-arm clinical study to explore the efficacy, safety and efficacy of finerenone in patients with primary aldosteronism

Recruiting
N/A
34
 
Use the drug of finerenone
Tianjin Medical University General Hospital; Tianjin Medical University General Hospital, Self-funded
Primary aldosteronism
 
 
ChiCTR2300073929: Effect of finerenone combined with canagliflozin on urinary protein in patients with chronic kidney disease with type 2 diabetes mellitus: A randomized controlled trial

Not yet recruiting
N/A
100
 
finerenone in combination with canagliflozin ;finerenone
The Third Hospital of Mianyang, Sichuan Mental Health Center; The Third Hospital of Mianyang, Health Commission of Mianyang City
chronic kidney disease with type 2 diabetes mellitus
 
 
SMART-Finder, NCT05552339: A Study Called to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients

Recruiting
N/A
5000
Europe
Finerenone (Kerendia, BAY94-8862), Type 2 DM drugs
Bayer
Type 2 Diabetes Mellitus, Chronic Kidney Disease
11/25
11/25
ChiCTR2400086359: Efficacy and safety study of RASI combined with SGLT2I, finasteride and hydroxychloroquine in the treatment of idiopathic membranous nephropathy

Not yet recruiting
N/A
70
 
After receiving the maximum tolerated dose of ACEI/ARB for 4 weeks, the treatment was combined with finerenone and SGLT2i. The finerenone regimen was 10 mg orally, 1/day for 26 weeks, and the SGLT2i regimen was dapagliflozin 10 mg orally, 1/day for 26 weeks; ; After 4 weeks of ACEI/ARB treatment at the maximum tolerated dose, the treatment was combined with finerenone, SGLT2I and hydroxychloroquine; the finerenone regimen was 10 mg orally, 1/day for 26 weeks; the SGLT2i regimen was dapagliflozin 10 mg orally, 1/day for 26 weeks; and hydroxychloroquine regimen was 400 mg/day orally for 26 weeks in patients with a body weight of ≥50 kg and 300 mg/d orally in patients with a body weight of <50 kg for 26 weeks.
The First Affiliated Hospital of the People's Liberation Army Air Force University of Military Medicine; Xijing hospital, self-finance
membranous neohropathy
 
 
NCT05348733: A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Recruiting
N/A
4500
Europe, Canada, US, RoW
Kerendia (Finerenone, BAY94-8862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
09/27
01/28
ChiCTR2500099594: The randomized controlled trial of finerenone therapy for pediatric Hennoch Scholein Purpura nephritis with mild proteinuria

Not yet recruiting
N/A
116
 
finerenone treatment; Primary therapy
children’hospital capital institute of pediatric; children’hospital capital institute of pediatric, Beijing Research Ward Excellence Program
children of HSPN with mild proteinuria
 
 
ChiCTR2400084561: An open randomized controlled trial to compare the efficacy and safety of finerenone and spironolactone in the treatment of primary aldosteronism

Not yet recruiting
N/A
160
 
finerenone; spironolactone
SUN YAT-SEN MEMORIAL HOSPITAL; SUN YAT-SEN MEMORIAL HOSPITAL, Sun Yat-sen Memorial Hospital Clinical Research 5010 Program
primary aldosteronism
 
 
Advantan (methylprednisolone aceponate) / Bayer
2016-000409-35: Explorative study on the clinical efficacy and tolerability of methylprednisolone aceponate cream and a new topical medical device in paediatric patients with mild to moderate Atopic Dermatitis, testing two different application modalities in the same patient on flexural contralateral lesions. Studio Esplorativo sull’Efficacia e la Tollerabilità di una Crema a base di Metilprednisolone Aceponato ed un Nuovo Dispositivo Medico Topico in Pazienti Pediatrici con Dermatite Atopica Lieve o Moderata, attraverso la Valutazione di Due Differenti Modalità di Applicazione nello Stesso Paziente su Lesioni Controlaterali Flessurali.

Ongoing
4
150
Europe
Bepanthenol Sensiderm®, Methylprednisolone aceponate, Cream, Bepanthenol Sensiderm®
Bambino Gesù Children's Hospital, Bayer S.p.A
Atopic Dermatitis Dermatite Atopica, Chronic inflammatory disease of the skin Malattia infiammatoria cronica della pelle, Body processes [G] - Physical Phenomena [G01]
 
 
2019-001324-35: A clinical study of adherence to methylprednisolone aceponate on different carriers

Not yet recruiting
4
80
Europe
Cream, Ointment, Advantan® Cream 0.1%, Advantan® Fatty Ointment 0.1%
Friedrich-Schiller-University Jena, BAYER CONSUMER CARE AG
Hand eczema, Inflammation of the skin on the hands, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
ACTRN12622001295730: Pilot study of a branded (marketed) formulation methylprednisolone aceponate called Advantan ointment applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.

Completed
4
12
 
Zenith Technology Corporation Limited, Nova Chem Australasia Pty Ltd
Advantan ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.
 
 
ACTRN12623000272695: Pilot study of a branded (marketed) formulation methylprednisolone aceponate called Advantan fatty ointment applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.

Completed
4
12
 
Zenith Technology Corporation Limited, Nova Chem Australasia Pty Ltd
Advantan fatty ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.
 
 
2022-002644-48: Clinical study to compare two cutaneous creams with the active substance methylprednisolone aceponate 0.1% and one cutaneous cream without active substance for patients with atopic dermatitis.

Not yet recruiting
3
330
Europe
Advantan 0.1% Creme, Methylprednisolone Aceponate 0.1% Cream, D07AC14, Cream, Advantan 0,1% Creme
Dermapharm AG, Dermapharm AG
Atopic dermatitis, Atopic dermatitis, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
2019-002686-35: Clinical study to compare two cutaneous ointments with the active substance methylprednisolone aceponate 0.1% and one cutaneous ointment without active substance for patients with atopic dermatiits.

Ongoing
3
330
Europe
Advantan 0,1% Salbe, Methylprednisolone Aceponate 0.1%, D07AC14, Ointment, Advantan 0,1% Salbe
Dermapharm AG, Dermapharm AG
Atopic dermatitis, Atopic dermatitis, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
Nubeqa (darolutamide) / Bayer, Orion Corp
NCT05348876: A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Recruiting
4
50
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer
01/26
01/26
COAction, NCT06627530: COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Not yet recruiting
4
144
NA
Darolutamide Oral Tablet, leuprorelin
Brazilian Clinical Research Institute, Bayer
Prostate Cancer
03/26
09/26
NCT06660862: Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Not yet recruiting
4
80
US
Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
University of Chicago
Prostate Cancer
11/29
11/29
ChiCTR2200057479: DAROL: An observational study of darotamine in patients with non-metastatic castration-resistant prostate cancer

Recruiting
4
1000
 
Darolutamide
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Bayer Aktiengesellschaft, Bayer AG
Castration-resistant prostate cancer
 
 
2019-004818-34: A clinical research study to investigate whether the addition of a new medication (darolutamide) to standard treatment is better for improving the outcomes for men with localised prostate cancer compared to standard treatment.

Not yet recruiting
3
1100
Europe
Darolutamide, BAY 1841788 (darolutamide, ODM-201), Film-coated tablet
Cancer Trials Ireland, Bayer, NHMRC Clinical Trials Centre (CTC), University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer (ANZUP)
Clinically localised prostate cancer defined as very high risk, or with very high risk features., Clinically localised prostate cancer defined as very high risk, or with very high risk features., Diseases [C] - Cancer [C04]
 
 
2020-003093-48: A trial to learn how well darolutamide plus androgen deprivation therapy (ADT) works in comparison to placebo plus ADT in men with prostate cancer that has spread to other parts of their body

Not yet recruiting
3
665
Europe
Darolutamide 300mg film-coated tablet, BAY 1841788, Film-coated tablet, NUBEQA
Bayer Consumer Care AG, Bayer Consumer Care AG
Metastatic hormone-sensitive prostate cancer (mHSPC), Metastatic prostate cancer responsive to hormone therapy which works by either stopping the body from making testosterone, or by stopping testosterone from reaching the cancer cells., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
ARASENS, NCT02799602 / 2015-002590-38: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Completed
3
1306
Europe, Canada, Japan, US, RoW
BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
Bayer, Orion Corporation, Orion Pharma
Metastatic Hormone-sensitive Prostate Cancer
10/21
04/23
2021-003542-21: Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial evaluating dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases. Etude de phase III randomisée multicentrique contrôlée contre placebo évaluant l’ajout du darolutamide à l’hormonothérapie et à la radiothérapie chez des patients atteints d’un cancer de prostate avec des métastases ganglionnaires pelviennes.

Ongoing
3
152
Europe
DAROLUTAMIDE, NUBEQA, Film-coated tablet, NUBEQA
ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, BAYER
Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Diseases [C] - Cancer [C04]
 
 
NCT06177015: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Recruiting
3
200
RoW
Darolutamide continuous, Darolutamide, Darolutamide intermittent
The First Affiliated Hospital with Nanjing Medical University
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
12/25
12/27
ARANOTE, NCT04736199 / 2020-003093-48: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Active, not recruiting
3
669
Europe, Canada, RoW
Darolutamide (Nubeqa, BAY1841788), Placebo, Androgen deprivation therapy (ADT)
Bayer, Orion Corporation, Orion Pharma
Prostatic Neoplasms
06/24
09/25
GETUG-AFU 42, NCT06496581: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

Recruiting
3
500
Europe
177Lu-PMSA-617, Pluvicto®, Standard of Care, ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy
UNICANCER, Novartis
Prostate Cancer Metastatic
02/33
08/39
PEACE8, NCT06276465: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Recruiting
3
336
Europe
Darolutamide 300 mg, Nubeqa, Stereotactic body radiation therapy, SBRT, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostatic Cancer, Castration-Resistant
10/29
10/32
ARASAFE, NCT05676203: A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Active, not recruiting
3
250
Europe
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
Jena University Hospital, Bayer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
07/25
01/27
TRIPLE-SWITCH, NCT06592924: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Not yet recruiting
3
830
NA
Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), Docetaxel, ADT
Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, Alliance for Clinical Trials in Oncology, SWOG Cancer Research Network
Prostate Cancer (Adenocarcinoma)
03/31
04/31
PEACE 7, NCT06625970: Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

Not yet recruiting
3
700
NA
Darolutamide, Stereotactic Body RadioTherapy (SBRT), ADT (Standard of Care), LHRH agonists, LHRH antagonists, radiotherapy, Normo-fractionated radiotherapy, Hypo-fractionated radiotherapy, intensity modulated radiotherapy (IMRT), whole pelvic nodal radiotherapy (WPRT)
UNICANCER, Bayer
High Risk Prostate Carcinoma, Prostate Cancer
10/33
10/45
ARAMIS Rollover, NCT04464226 / 2019-003618-15: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Recruiting
3
402
Europe, Canada, Japan, US, RoW
Darolutamide (Nubeqa, BAY1841788), ODM-201
Bayer
Cancer
06/28
06/28
ALADDIN, NCT05116475: Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Recruiting
3
152
Europe
Darolutamide 300 mg, Placebo of Darolutamide
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, Bayer
Prostate Cancer
02/26
02/27
ProBio, NCT03903835 / 2018-002350-78: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting
3
750
Europe
Enzalutamide Oral Capsule, Xtandi, Abiraterone Oral Tablet, Zytiga, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution, Radium Chloride Ra-223, Xofigo, Niraparib plus Abiraterone acetate plus Prednisone, Akeega, Capivasertib plus Docetaxel, Apalutamide, Erleada, Darolutamide, Nubeqa
Karolinska Institutet, The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
12/26
12/26
ARASTEP, NCT05794906: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Recruiting
3
970
Europe, Canada, Japan, US, RoW
Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
Bayer
Biochemically Recurrent Prostate Cancer
07/27
03/30
EvoPAR-PR01, NCT06120491: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Recruiting
3
1800
Europe, Canada, Japan, US, RoW
Saruparib, AZD5305, Placebo, Abiraterone Acetate, Zytiga, Darolutamide, Nubequa, Enzalutamide, Xtandi
AstraZeneca
Metastatic Castration-Sensitive Prostate Cancer
01/28
04/31
DASL-HiCaP, NCT04136353: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active, not recruiting
3
1100
Europe, Canada, US, RoW
Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Prostate Cancer
01/28
07/28
PEACE6-Unfit, NCT04916613 / 2020-003663-26: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Recruiting
3
300
Europe
Darolutamide 300 mg, Nubeqa®, Placebo, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostate Cancer Metastatic
03/28
09/37
ERADICATE, NCT04484818: Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The Study

Active, not recruiting
3
27
US
Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, ODM 201, ODM-201, Goserelin Acetate, ZDX, Zoladex, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Prostate Carcinoma
12/25
05/28
CARE, NCT05771896: Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Withdrawn
3
514
NA
Darolutamide, Nubeqa, Radium-223, Xofigo
GenesisCare USA, Bayer
Metastatic Prostate Cancer
12/28
04/29
A Phase III study comparing darolutamide plus ADT versus placebo plus ADT in high-risk BCR patients, ChiCTR2400082864:

Not yet recruiting
3
750
 
Placebo plus ADT; Darolutamide plus ADT
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Bayer Consumer Care AG
Hormone-sensitive prostate cancer is at high risk for biochemical recurrence
 
 
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
THUNDER, NCT06282588: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting
2/3
493
Europe
Darolutamide, Nubeqa, BAY1841788, Darolutamide matched placebo, BAY1841788 matched placebo, Radiotherapy, Zoladex 3.6Mg Implant, Goserelin acetate 3.6 mg, Zoladex LA, Goserelin acetate 10.8 mg, Decapeptyl sustained release 22.5 mg, Triptorelin 11.25 mg, Decapeptyl sustained release 11.25 mg, Depo-Eligard 45 mg, Leuprorelin acetate 45 mg, Depo-Eligard 22.5 mg, Leuprorelin acetate 22.5 mg, Depo-Eligard 7.5 mg, Leuprorelin acetate 7.5 mg, Firmagon 120 MG Injection, Degarelix 40 mg, Firmagon 80 MG Injection, Degarelix 20 mg, Docetaxel, Taxotere
Cancer Research Antwerp, Bayer, Veracyte, Inc.
Prostate Cancer
07/30
12/30
ACTRN12623000160639: A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)

Not yet recruiting
2
32
 
St Vincent's Hospital Sydney, St Vincent's Hospital Sydney
Prostate cancer
 
 
ACTRN12624001458527: A study of opaganib in addition to darolutamide in participants with metastatic hormone resistant prostate cancer, selected for the presence of a specific biomarker.

Not yet recruiting
2
60
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Ramsay Foundation , Bayer Australia Limited
Prostate Cancer
 
 
ACTRN12624000582550: Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide.

Recruiting
2
69
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer
Prostate Cancer
 
 
2019-004952-13: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)

Not yet recruiting
2
140
Europe
ODM-201, BAY1841788, Film-coated tablet, NUBEQA
University Hospital Ghent, Bayer Consumer Care AG
- Prostate cancer patients with a biochemical recurrence following primary therapy- Hormone-sensitive- Up to 5 metastases on PSMA PET-CT, Prostate Cancer, Diseases [C] - Cancer [C04]
 
 
SAKK 08/16, NCT02933801 / 2016-003996-23: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

Terminated
2
92
Europe
ODM-201, BAY-1841788, Placebo
Swiss Group for Clinical Cancer Research
Prostate Cancer Metastatic, Prostate Cancer
06/21
11/23
2020-000823-38: Study on the interaction between cabazitaxel and darolutamide in patients with metastatic prostate cancer Studie naar de wisselwerking tussen cabazitaxel en darolutamide bij patiënten met uitgezaaide prostaatkanker

Not yet recruiting
2
17
Europe
Tablet, Infusion, darolutamide, Cabazitaxel
Erasmus MC Cancer Institute, Erasmus MC Cancer Institute
metastatic castration-resistant prostate cancer Gemetastaseerde castratie-resistente prostaatkanker, Prostate cancer spread to other parts of the body Uitgezaaide prostaatkanker, Diseases [C] - Cancer [C04]
 
 
ODENZA, NCT03314324 / 2017-001606-14: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

Active, not recruiting
2
250
Europe
ODM-201, Enzalutamide
Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Castrate-resistant Prostate (CRPC) Cancer
01/22
10/24
2022-002431-53: A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER DAROLUTAMIDE (ODM-201) CONCOMITANT A LA RADIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER DE LA PROSTATE A RISQUE INTERMEDIAIRE DEFAVORABLE : UNE ETUDE MULTICENTRIQUE RANDOMISEE NON-COMPARATIVE DE PHASE II

Ongoing
2
62
Europe
DAROLUTAMIDE, Dégarélix, Goséréline, Leuproréline, Triptoréline, RADIOTHERAPY, Tablet, Powder and solvent for solution for injection, Implant in pre-filled syringe, , NUBEQA, FIRMAGON, ZOLADEX, ELIGARD, ENANTONE, DECAPEPTYL, GONAPEPTYL, RADIOTHERAPY
Institut Bergonié, Bayer Healthcare SAS
Prostate cancer Cancer de la prostate, Intermediate unfavorable risk prostate cancer Cancer de la prostate à risque intermédiaire défavorable, Diseases [C] - Cancer [C04]
 
 
NCT05249712: Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Recruiting
2
30
RoW
Darolutamide 300 mg, Nubeqa, BAY1841788, Androgen deprivation therapy, ADT
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University
Prostate Cancer
01/23
12/25
2022-003792-41: Chemotherapy with or without darolutamide in men with metastatic prostate cancer.

Not yet recruiting
2
245
Europe
Nubeqa, Tablet, Nubeqa/Darolutamide
Erasmus MC, Bayer
metastatic castration-resistant prostate cancer, Prostate cancer spread to other parts of the body, Diseases [C] - Cancer [C04]
 
 
NCT06173362: Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting
2
75
US
Abiraterone, CB 7598, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Mamta Parikh, National Cancer Institute (NCI)
Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
11/26
05/27
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Kerendia (finerenone) / Bayer
2021-001661-21: Feasibility of aggressively lowering urine albumin in individuals with kidney biopsy-proven diabetic kidney disease - A Pilot Study

Not yet recruiting
4
20
Europe
Tablet, Injection, Forxiga, Jardiance, Ozempic, Telmisartan, Losartan, hydrochlorthiazide, Spironolactone, Trental, Olumiant, Kerendia, Rybelsus
Herlev and Gentofte Hospital, Herlev and Gentofte Hospital
Diabetic Kidney Disease, Kidney Disease due to diabetes mellitus type 2, Diseases [C] - Hormonal diseases [C19]
 
 
NCT05924620: Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Completed
4
60
RoW
finerenone, Kerendia
Chongqing Medical University
Primary Aldosteronism
03/24
03/24
FAVOR, NCT06164379: Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

Not yet recruiting
4
150
RoW
Finerenone, Spironolactone
Shanghai Jiao Tong University School of Medicine
Primary Aldosteronism
12/24
12/24
NCT06381323: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Recruiting
4
55
RoW
Finerenone, Nifedipine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Primary Aldosteronism, Finerenone, Mineralocorticoid Receptor Antagonist
03/27
04/27
NCT06457074: Finerenone for Patients With Primary Aldosteronism (FAIRY)

Recruiting
4
306
RoW
Finerenone Oral Tablet, Finerenone, Spironolactone Oral Tablet, Spironolactone
Qifu Li, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Changzhi Medical College
Primary Aldosteronism
06/25
06/26
Optimize@Home, NCT06094920: Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial

Enrolling by invitation
4
10
Europe
Empagliflozin 10 MG, Jardiance, A10BK03, (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol, Finerenone, Kerendia, C03DA05, (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide, Withings BPM Connect, Withings Body, PeeSpot Urine Collection Device, Hem-Col Capillary Blood Collection Device, Questionnaire: participants' perspectives toward the feasibility of participation in a trial at home with digital technologies
University Medical Center Groningen, Boehringer Ingelheim
Diabetes Mellitus Type 2 With Proteinuria, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetes, Diabetes Complications, Albuminuria, Chronic Kidney Diseases, Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, CKD, CKD Stage 3, CKD Stage 4
10/24
11/24
NCT06573411: Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

Not yet recruiting
4
88
NA
ACEI/ARB+ finerenone, ACEI/ARB+ Placebo
First Affiliated Hospital, Sun Yat-Sen University
Primary Membranous Nephropathy
10/25
10/25
RAiSiN, NCT06727409: Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i As Triple Therapy with Type 2 Diabetes and Chronic Kidney Disease

Recruiting
4
82
RoW
Finerenone
Chinese University of Hong Kong
Patients with Type 2 Diabetes
07/26
12/26
FIVE-STAR, NCT05887817: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD

Active, not recruiting
4
100
Japan
Finerenone, Kerendia, Placebo
Saga University
Type 2 Diabetes, Chronic Kidney Diseases
02/25
07/26
NCT05814770: Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Not yet recruiting
4
96
NA
Finerenone, Kerendia, Spironolactone
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, National Key Research and Development Program of China, National Natural Science Foundation of China
Primary Aldosteronism, Hypertension
03/25
03/26
ChiCTR2300078226: Efficacy and safety of initial treatment of Finerenone combined with Henagliflozein in patients with type 2 diabetes with microalbuminuria: a randomized, parallel, controlled, three-arm clinical study

Recruiting
4
300
 
Losartan 50mg qd combined with Henagliflozein 5mg qd; Losartan 50mg qd combined with Finerenone 10mg qd; Losartan 50mg qd in combination with Finerenone 10mg qd and Henagliflozein 5mg qd
Peking University First Hospital; Peking University First Hospital, self-funded
Type 2 diabetes
 
 
ChiCTR2400086830: Mechanism study of finerenone in the treatment of diabetic kidney disease

Not yet recruiting
4
300
 
finerenone treatment; ACEI or ARB; None
The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Zhengzhou University
diabetic kidney disease
 
 
NCT05705271: A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus

Active, not recruiting
4
200
RoW
Finerenone (Kerendia, BAY94-8862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
07/25
07/25
ChiCTR2300069660: Compare the Efficacy and Safety of Finerenone, a New Type of Mineralocorticoid Receptor Antagonist, and Spironolactone in the Treatment of Primary Aldosteronism: a Single-Center, Prospective, Randomized Controlled Study

Not yet recruiting
4
96
 
Finerenone ;Spironolactone
Drum Tower Hospital Affiliated to Nanjing University Medical School; Drum Tower Hospital Affiliated to Nanjing University Medical School, National Key Research and Development Program of China (2021YFC2501600, 2021YFC2501603)
Primary Aldosteronism
 
 
EMRACVDHHA, NCT05688579: Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia

Enrolling by invitation
4
8000
RoW
Mineralocorticoid Receptor Antagonists(MRAs), Blank control, Placebo
Nanfang Li
Hypertension, Hyperaldosteronaemia
12/26
12/26
2015-002168-17: Efficacy and safety of finerenone in subjects with chronic heart failure at high risk of recurrent heart failure decompensation

Ongoing
3
5890
Europe, RoW
BAY 94-8862 IR tablet 10 mg, BAY 94-8862 IR tablet 20 mg, Eplerenone 25 mg Film-coated Tablets, Eplerenone 50 mg Film-coated Tablets, BAY 94-8862 coated tablet 10 mg, BAY 94-8862 coated tablet 20 mg, Film-coated tablet, Eplerenone 25 mg Film-coated Tablets, Eplerenone 50 mg Film-coated Tablets
Bayer HealthCare AG, Bayer HealthCare AG
Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both, CHF (reduction of the pumping capacity of the heart), DM type 2 (body's ineffective use of insulin) and CKD (kidneys fail to adequately filter toxins and waste products from the blood), Diseases [C] - Cardiovascular Diseases [C14]
 
 
NCT06244758: Finerenone and Renal Oxidative Stress

Recruiting
3
75
Europe
Finerenone 20 MG Oral Tablet, Placebo
University of Erlangen-Nürnberg Medical School, Bayer
Type2diabetes
06/25
12/25
FINEARTS-HF, NCT04435626 / 2020-000306-29: Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

Completed
3
6016
Europe, Canada, Japan, US, RoW
Finerenone (BAY94-8862), Placebo
Bayer
Heart Failure
05/24
06/24
FIGHT, NCT06580288: Effect of Finerenone in IgA Nephropathy

Not yet recruiting
3
120
NA
Finerenone, Placebo
Zhejiang University
IgA Nephropathy
06/26
10/26
CONFIRMATION, NCT06024746: A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (-HF)

Recruiting
3
1500
Canada, US, RoW
Finerenone, Empagliflozin
Colorado Prevention Center, Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Heart Failure
07/26
08/26
FINE-ONE, NCT05901831: A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes

Active, not recruiting
3
220
Europe, Canada, US, RoW
Finerenone, Placebo
Bayer
Chronic Kidney Disease, Type 1 Diabetes Mellitus
08/25
09/25
FIND-CKD, NCT05047263 / 2021-000421-27: A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

Active, not recruiting
3
1584
Europe, Japan, US, RoW
Finerenone (BAY94-8862), Placebo
Bayer
Non-diabetic Chronic Kidney Disease
01/26
02/26
REDEFINE-HF, NCT06008197: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Recruiting
3
5200
US
Finerenone, Kerendia, Placebo
Colorado Prevention Center, Saint Luke's Hospital of Kansas City, Bayer
Heart Failure, Acute Heart Failure
04/26
04/26
FINALITY-HF, NCT06033950: A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

Recruiting
3
2600
Canada, US, RoW
Finerenone, Placebo
Colorado Prevention Center, St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Heart Failure
03/28
04/28
FIONA, NCT05196035 / 2021-002071-19: A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Recruiting
3
219
Europe, Canada, US, RoW
Finerenone (Kerendia, BAY94-8862), Placebo
Bayer
Chronic Kidney Disease, Proteinuria
07/27
08/27
CAPTIVATE, NCT06058585: The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Recruiting
3
1000
RoW
Finerenone, BAY94-8862, Placebo Finerenone
The George Institute
Chronic Kidney Diseases
08/28
12/28
FIONA OLE, NCT05457283 / 2021-002905-89: A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Recruiting
3
100
Europe, Canada, US, RoW
Finerenone (Kerendia, BAY94-8862)
Bayer, Bayer AG
Chronic Kidney Disease, Proteinuria, Children
01/29
02/29
Steno1, NCT06082063: Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Recruiting
3
2000
Europe
Aspirin tablet, Semaglutide, Sotagliflozin, Finerenone
Steno Diabetes Center Copenhagen, Aarhus University Hospital, Steno Diabetes Center Nordjylland, Steno Diabetes Center Odense, Slagelse Hospital, Nykøbing Falster County Hospital, Zealand University Hospital, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Herning Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Regionshospitalet Silkeborg, Bispebjerg Hospital, Regionshospitalet Horsens
Cardiovascular Diseases, Heart Failure, Type 1 Diabetes, Kidney Failure
07/29
07/29
2020-003865-20: A study that uses data from routine eye examinations of patients participating in studies FIDELIO-DKD and FIGARO-DKD to explore whether Finerenone can delay the progression of a diabetes complication that affects the eyes (diabetic retinopathy ,DR)

Not yet recruiting
2
90
Europe
Finerenone, BAY 94-8862 IR tablet 10 mg, Film-coated tablet
Bayer AG, Bayer AG
Diabetic Retinopathy, An eye condition called diabetic retinopathy (DR) that affects people with diabetes. People with DR have damage to the blood vessels in the tissue at the back of the eye called the retina., Diseases [C] - Cardiovascular Diseases [C14]
 
 
CONFIDENCE, NCT05254002 / 2021-003037-11: A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

Completed
2
1664
Europe, Canada, Japan, US, RoW
Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
Bayer
Type 2 Diabetes Mellitus, Chronic Kidney Disease
03/25
03/25
EFFEKTOR, NCT06059664: The EFfect of FinErenone in Kidney TransplantiOn Recipients: The Study

Recruiting
2
150
US
Finerenone Oral Tablet, Kerendia, Placebo, Sugar pill
University of North Carolina, Chapel Hill, Bayer
Kidney Transplant; Complications
02/25
05/26
EmFin-Nx, NCT06818305: Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: a Multicenter RCT

Recruiting
2
100
RoW
Finerenone (BAY 94-8862), Empagliflozin 10 mg
Jinling Hospital, China, The Affiliated Hospital of Xuzhou Medical University, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, The First Affiliated Hospital with Nanjing Medical University
Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Nephrectomy, Chronic Kidney Disease(CKD)
01/27
12/27
NCT06835322: Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Recruiting
2
100
RoW
Finerenone, Placebo
Alexandria University
Glomerulonephritis
08/25
09/25
FibroCAN, NCT06906081: Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the Study

Not yet recruiting
2
100
Europe
Kerendia (Finerenone, BAY94-8862), Placebo
Peter Rossing, Steno Diabetes Center Nordjylland, Aarhus University Hospital
Cardiovascular Autonomic Neuropathy, Type 2 Diabetes, Diabetic Neuropathies
11/27
11/27
WP3, NCT05897372: Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study

Terminated
2
1
Europe
ACEi / ARB, SGLT2i, finerenone, semaglutide, pentoxifylline, hydrochlorthiazide, baricitinib
Iain Bressendorff
Diabetic Kidney Disease
09/24
09/24
PolyPreventHF, NCT06143566: Polypill for Prevention of Cardiomyopathy

Recruiting
1/2
60
US
Polypill, (Finerenone, Empagliflozin, Losartan)
University of Texas Southwestern Medical Center
Type 2 Diabetes, High Blood Pressure
09/25
12/25
ChiCTR2400079455: A multicenter, randomized, double-blind, crossover controlled clinical study of the treatment of Alport syndrome with Henagliflozin, Finerenone, and combination therapy.

Recruiting
1
60
 
Henagliflozin: In the first cycle (from day 1 to day 60), patients assigned to the SGLT2i group were required to take the corresponding medication for one month (SGLT2i group: Henagliflozin 10mg qd + 1 tablet of Finerenone placebo), followed by one month of placebo washout (2 placebos, including 1 SGLT2 placebo + 1 MRA placebo). In the second cycle (from day 61 to day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug treatment from the first cycle (one subgroup received MRA + SGLT2i placebo, and the other subgroup received SGLT2i + MRA). In the third cycle (from day 121 to day 180): each group of patients received a different drug treatment plan from the first and second cycles for one month, followed by one month of placebo washout.; Finerenone: The first cycle (from day 1 to day 60) involved patients randomly assigned to the MRA group who were required to take the corresponding medication for one month (MRA group: Finerenone 10mg qd + 1 tablet of Henagliflozin placebo), followed by one month of placebo washout. In the second cycle (from day 61 to day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug treatment from the first cycle (one subgroup received SGLT2i + MRA placebo, and the other subgroup received SGLT2i + MRA). In the third cycle (from day 121 to day 180): each group of patients received a different drug treatment plan from the first and second cycles for one month, followed by one month of placebo washout; Henagliflozin+Finerenone: The first cycle (Day 1 to Day 60) involved the random allocation of patients to the combination therapy group, where they were required to take the corresponding medication for one month (combination therapy group: empagliflozin 10mg qd + finerenone 10mg qd), followed by one month of placebo. In the second cycle (Day 61 to Day 120), the patients in this group were randomly divided into two subgroups, each receiving a different drug regimen from the first cycle (one subgroup received SGLT2i + MRA placebo, and the other subgroup received SGLT2i placebo + MRA). The third cycle (Day 121 to Day 180) involved each group of patients receiving a different drug treatment plan from both the first and second cycles for one month, followed by one month of placebo washout.
peking university first hospital; peking university first hospital, Undertaking by the investigator
Alport syndrome
 
 
NCT02378805: Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome

Recruiting
N/A
800
Europe
ACE-inhibitor, Angiotensin-receptor blocker (ARB), HMG-Coenzyme inhibitor (statin), Spironolactone or Finerenone, Paricalcitol, SGLT2 inhibitor
University Hospital Goettingen, Society for Pediatric Nephrology (Germany)
Alport Syndrome, Hereditary Kidney Disease, Pediatric Kidney Disease, Thin Basement Membrane Disease, Familial Benign Hematuria
03/36
03/36
NCT06460987: Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

Completed
N/A
245
RoW
Finerenone, FINE, RAS inhibitor, RASI, Immune Suppressant, immunosupressive
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Finerenone, IgA Nephropathy, Proteinuria, Safety Issues
03/24
03/24
NCT06301022: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus

Recruiting
N/A
90
RoW
First Affiliated Hospital of Harbin Medical University
Chronic Kidney Diseases
10/24
12/24
NCT05974566: Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction

Not yet recruiting
N/A
60
NA
Chongqing Medical University
Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Diabetic Nephropathies
09/23
10/23
FLAMINGO, NCT05640180: An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results

Completed
N/A
17847
US
Finerenone (Kerendia, BAY94-8862), Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
Bayer
Chronic Kidney Disease, Type 2 Diabetes
12/23
12/23
KSD-01, NCT06838416: Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

Recruiting
N/A
300
RoW
Finerenone, Angiotensin II Receptor Blockers
Second Affiliated Hospital of Soochow University
Type 2 Diabetes Mellitus, Chronic Kidney Disease, Renal Function
12/25
12/26
FIRST-2, NCT05703880: An Observational Study Called .0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Completed
N/A
15948
US
Finerenone (Kerendia, BAY948862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/24
10/24
FINEROD, NCT06278207: An Observational Study Called to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Recruiting
N/A
50000
Europe, Japan, US
Finerenone (BAY 94-8862), Kerendia, Firialta
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/25
10/25
FINEGUST, NCT05526157: An Observational Study, Called , to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice

Completed
N/A
50000
Europe, Japan, US
Finerenone (Kerendia, BAY 948862), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Steroidal mineral corticoid receptor antagonists (sMRA), Non-steroidal mineral corticoid receptor antagonists (nsMRA)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
09/24
09/24
NCT06608212: An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States

Active, not recruiting
N/A
150000
US
Finerenone (Kerendia, BAY948862), Others except finerenone
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
06/25
06/25
ChiCTR2400087169: Efficacy and safety of Finerenone in patients with type 2 diabetes mellitus combined with chronic kidney disease in a "in person-remote" diabetes mellitus self-management support model: a single-center retrospective real-world study

Not yet recruiting
N/A
1420
 
Continuous application of Finerenone for at least 3 months at the Diabetes Shared Care Real World Management Follow-Up; CKD adjudicated at the Diabetes Shared Care Real World Management Follow-Up, but not clinically applied Finerenone
Peking University First Hospital; Peking University First Hospital, self-funded
Type 2 Diabetes Mellitus
 
 
IN-REALITY, NCT06763146: An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice

Not yet recruiting
N/A
1200
RoW
Finerenone (Kerendia, BAY948862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
10/25
10/25
ChiCTR2400090272: An open-label, single-arm clinical study to explore the efficacy, safety and efficacy of finerenone in patients with primary aldosteronism

Recruiting
N/A
34
 
Use the drug of finerenone
Tianjin Medical University General Hospital; Tianjin Medical University General Hospital, Self-funded
Primary aldosteronism
 
 
ChiCTR2300073929: Effect of finerenone combined with canagliflozin on urinary protein in patients with chronic kidney disease with type 2 diabetes mellitus: A randomized controlled trial

Not yet recruiting
N/A
100
 
finerenone in combination with canagliflozin ;finerenone
The Third Hospital of Mianyang, Sichuan Mental Health Center; The Third Hospital of Mianyang, Health Commission of Mianyang City
chronic kidney disease with type 2 diabetes mellitus
 
 
SMART-Finder, NCT05552339: A Study Called to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients

Recruiting
N/A
5000
Europe
Finerenone (Kerendia, BAY94-8862), Type 2 DM drugs
Bayer
Type 2 Diabetes Mellitus, Chronic Kidney Disease
11/25
11/25
ChiCTR2400086359: Efficacy and safety study of RASI combined with SGLT2I, finasteride and hydroxychloroquine in the treatment of idiopathic membranous nephropathy

Not yet recruiting
N/A
70
 
After receiving the maximum tolerated dose of ACEI/ARB for 4 weeks, the treatment was combined with finerenone and SGLT2i. The finerenone regimen was 10 mg orally, 1/day for 26 weeks, and the SGLT2i regimen was dapagliflozin 10 mg orally, 1/day for 26 weeks; ; After 4 weeks of ACEI/ARB treatment at the maximum tolerated dose, the treatment was combined with finerenone, SGLT2I and hydroxychloroquine; the finerenone regimen was 10 mg orally, 1/day for 26 weeks; the SGLT2i regimen was dapagliflozin 10 mg orally, 1/day for 26 weeks; and hydroxychloroquine regimen was 400 mg/day orally for 26 weeks in patients with a body weight of ≥50 kg and 300 mg/d orally in patients with a body weight of <50 kg for 26 weeks.
The First Affiliated Hospital of the People's Liberation Army Air Force University of Military Medicine; Xijing hospital, self-finance
membranous neohropathy
 
 
NCT05348733: A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Recruiting
N/A
4500
Europe, Canada, US, RoW
Kerendia (Finerenone, BAY94-8862)
Bayer
Chronic Kidney Disease, Type 2 Diabetes Mellitus
09/27
01/28
ChiCTR2500099594: The randomized controlled trial of finerenone therapy for pediatric Hennoch Scholein Purpura nephritis with mild proteinuria

Not yet recruiting
N/A
116
 
finerenone treatment; Primary therapy
children’hospital capital institute of pediatric; children’hospital capital institute of pediatric, Beijing Research Ward Excellence Program
children of HSPN with mild proteinuria
 
 
ChiCTR2400084561: An open randomized controlled trial to compare the efficacy and safety of finerenone and spironolactone in the treatment of primary aldosteronism

Not yet recruiting
N/A
160
 
finerenone; spironolactone
SUN YAT-SEN MEMORIAL HOSPITAL; SUN YAT-SEN MEMORIAL HOSPITAL, Sun Yat-sen Memorial Hospital Clinical Research 5010 Program
primary aldosteronism
 
 
Advantan (methylprednisolone aceponate) / Bayer
2016-000409-35: Explorative study on the clinical efficacy and tolerability of methylprednisolone aceponate cream and a new topical medical device in paediatric patients with mild to moderate Atopic Dermatitis, testing two different application modalities in the same patient on flexural contralateral lesions. Studio Esplorativo sull’Efficacia e la Tollerabilità di una Crema a base di Metilprednisolone Aceponato ed un Nuovo Dispositivo Medico Topico in Pazienti Pediatrici con Dermatite Atopica Lieve o Moderata, attraverso la Valutazione di Due Differenti Modalità di Applicazione nello Stesso Paziente su Lesioni Controlaterali Flessurali.

Ongoing
4
150
Europe
Bepanthenol Sensiderm®, Methylprednisolone aceponate, Cream, Bepanthenol Sensiderm®
Bambino Gesù Children's Hospital, Bayer S.p.A
Atopic Dermatitis Dermatite Atopica, Chronic inflammatory disease of the skin Malattia infiammatoria cronica della pelle, Body processes [G] - Physical Phenomena [G01]
 
 
2019-001324-35: A clinical study of adherence to methylprednisolone aceponate on different carriers

Not yet recruiting
4
80
Europe
Cream, Ointment, Advantan® Cream 0.1%, Advantan® Fatty Ointment 0.1%
Friedrich-Schiller-University Jena, BAYER CONSUMER CARE AG
Hand eczema, Inflammation of the skin on the hands, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
ACTRN12622001295730: Pilot study of a branded (marketed) formulation methylprednisolone aceponate called Advantan ointment applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.

Completed
4
12
 
Zenith Technology Corporation Limited, Nova Chem Australasia Pty Ltd
Advantan ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.
 
 
ACTRN12623000272695: Pilot study of a branded (marketed) formulation methylprednisolone aceponate called Advantan fatty ointment applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.

Completed
4
12
 
Zenith Technology Corporation Limited, Nova Chem Australasia Pty Ltd
Advantan fatty ointment is indicated for the topical treatment of eczema and psoriasis in children and adults.
 
 
2022-002644-48: Clinical study to compare two cutaneous creams with the active substance methylprednisolone aceponate 0.1% and one cutaneous cream without active substance for patients with atopic dermatitis.

Not yet recruiting
3
330
Europe
Advantan 0.1% Creme, Methylprednisolone Aceponate 0.1% Cream, D07AC14, Cream, Advantan 0,1% Creme
Dermapharm AG, Dermapharm AG
Atopic dermatitis, Atopic dermatitis, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
2019-002686-35: Clinical study to compare two cutaneous ointments with the active substance methylprednisolone aceponate 0.1% and one cutaneous ointment without active substance for patients with atopic dermatiits.

Ongoing
3
330
Europe
Advantan 0,1% Salbe, Methylprednisolone Aceponate 0.1%, D07AC14, Ointment, Advantan 0,1% Salbe
Dermapharm AG, Dermapharm AG
Atopic dermatitis, Atopic dermatitis, Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
Nubeqa (darolutamide) / Bayer, Orion Corp
NCT05348876: A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Recruiting
4
50
RoW
Darolutamide (Nubeqa, BAY1841788)
Bayer
Non-metastatic Castration-resistant Prostate Cancer
01/26
01/26
COAction, NCT06627530: COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Not yet recruiting
4
144
NA
Darolutamide Oral Tablet, leuprorelin
Brazilian Clinical Research Institute, Bayer
Prostate Cancer
03/26
09/26
NCT06660862: Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Not yet recruiting
4
80
US
Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
University of Chicago
Prostate Cancer
11/29
11/29
ChiCTR2200057479: DAROL: An observational study of darotamine in patients with non-metastatic castration-resistant prostate cancer

Recruiting
4
1000
 
Darolutamide
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Bayer Aktiengesellschaft, Bayer AG
Castration-resistant prostate cancer
 
 
2019-004818-34: A clinical research study to investigate whether the addition of a new medication (darolutamide) to standard treatment is better for improving the outcomes for men with localised prostate cancer compared to standard treatment.

Not yet recruiting
3
1100
Europe
Darolutamide, BAY 1841788 (darolutamide, ODM-201), Film-coated tablet
Cancer Trials Ireland, Bayer, NHMRC Clinical Trials Centre (CTC), University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer (ANZUP)
Clinically localised prostate cancer defined as very high risk, or with very high risk features., Clinically localised prostate cancer defined as very high risk, or with very high risk features., Diseases [C] - Cancer [C04]
 
 
2020-003093-48: A trial to learn how well darolutamide plus androgen deprivation therapy (ADT) works in comparison to placebo plus ADT in men with prostate cancer that has spread to other parts of their body

Not yet recruiting
3
665
Europe
Darolutamide 300mg film-coated tablet, BAY 1841788, Film-coated tablet, NUBEQA
Bayer Consumer Care AG, Bayer Consumer Care AG
Metastatic hormone-sensitive prostate cancer (mHSPC), Metastatic prostate cancer responsive to hormone therapy which works by either stopping the body from making testosterone, or by stopping testosterone from reaching the cancer cells., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
ARASENS, NCT02799602 / 2015-002590-38: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Completed
3
1306
Europe, Canada, Japan, US, RoW
BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
Bayer, Orion Corporation, Orion Pharma
Metastatic Hormone-sensitive Prostate Cancer
10/21
04/23
2021-003542-21: Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial evaluating dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases. Etude de phase III randomisée multicentrique contrôlée contre placebo évaluant l’ajout du darolutamide à l’hormonothérapie et à la radiothérapie chez des patients atteints d’un cancer de prostate avec des métastases ganglionnaires pelviennes.

Ongoing
3
152
Europe
DAROLUTAMIDE, NUBEQA, Film-coated tablet, NUBEQA
ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, BAYER
Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Prostate cancer with pelvic lymph nodes metastases. Cancer de la prostate avec des métastases ganglionnaires pelviennes., Diseases [C] - Cancer [C04]
 
 
NCT06177015: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Recruiting
3
200
RoW
Darolutamide continuous, Darolutamide, Darolutamide intermittent
The First Affiliated Hospital with Nanjing Medical University
Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy
12/25
12/27
ARANOTE, NCT04736199 / 2020-003093-48: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Active, not recruiting
3
669
Europe, Canada, RoW
Darolutamide (Nubeqa, BAY1841788), Placebo, Androgen deprivation therapy (ADT)
Bayer, Orion Corporation, Orion Pharma
Prostatic Neoplasms
06/24
09/25
GETUG-AFU 42, NCT06496581: Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

Recruiting
3
500
Europe
177Lu-PMSA-617, Pluvicto®, Standard of Care, ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy
UNICANCER, Novartis
Prostate Cancer Metastatic
02/33
08/39
PEACE8, NCT06276465: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Recruiting
3
336
Europe
Darolutamide 300 mg, Nubeqa, Stereotactic body radiation therapy, SBRT, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostatic Cancer, Castration-Resistant
10/29
10/32
ARASAFE, NCT05676203: A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Active, not recruiting
3
250
Europe
Standard ADT (androgen deprivation therapy), Standard Darolutamide, Docetaxel
Jena University Hospital, Bayer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
07/25
01/27
TRIPLE-SWITCH, NCT06592924: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Not yet recruiting
3
830
NA
Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), Docetaxel, ADT
Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, Alliance for Clinical Trials in Oncology, SWOG Cancer Research Network
Prostate Cancer (Adenocarcinoma)
03/31
04/31
PEACE 7, NCT06625970: Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

Not yet recruiting
3
700
NA
Darolutamide, Stereotactic Body RadioTherapy (SBRT), ADT (Standard of Care), LHRH agonists, LHRH antagonists, radiotherapy, Normo-fractionated radiotherapy, Hypo-fractionated radiotherapy, intensity modulated radiotherapy (IMRT), whole pelvic nodal radiotherapy (WPRT)
UNICANCER, Bayer
High Risk Prostate Carcinoma, Prostate Cancer
10/33
10/45
ARAMIS Rollover, NCT04464226 / 2019-003618-15: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Recruiting
3
402
Europe, Canada, Japan, US, RoW
Darolutamide (Nubeqa, BAY1841788), ODM-201
Bayer
Cancer
06/28
06/28
ALADDIN, NCT05116475: Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Recruiting
3
152
Europe
Darolutamide 300 mg, Placebo of Darolutamide
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, Bayer
Prostate Cancer
02/26
02/27
ProBio, NCT03903835 / 2018-002350-78: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting
3
750
Europe
Enzalutamide Oral Capsule, Xtandi, Abiraterone Oral Tablet, Zytiga, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution, Radium Chloride Ra-223, Xofigo, Niraparib plus Abiraterone acetate plus Prednisone, Akeega, Capivasertib plus Docetaxel, Apalutamide, Erleada, Darolutamide, Nubeqa
Karolinska Institutet, The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
12/26
12/26
ARASTEP, NCT05794906: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Recruiting
3
970
Europe, Canada, Japan, US, RoW
Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
Bayer
Biochemically Recurrent Prostate Cancer
07/27
03/30
EvoPAR-PR01, NCT06120491: Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Recruiting
3
1800
Europe, Canada, Japan, US, RoW
Saruparib, AZD5305, Placebo, Abiraterone Acetate, Zytiga, Darolutamide, Nubequa, Enzalutamide, Xtandi
AstraZeneca
Metastatic Castration-Sensitive Prostate Cancer
01/28
04/31
DASL-HiCaP, NCT04136353: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active, not recruiting
3
1100
Europe, Canada, US, RoW
Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
University of Sydney, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Prostate Cancer
01/28
07/28
PEACE6-Unfit, NCT04916613 / 2020-003663-26: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Recruiting
3
300
Europe
Darolutamide 300 mg, Nubeqa®, Placebo, Androgen deprivation therapy, ADT
UNICANCER, Bayer
Prostate Cancer Metastatic
03/28
09/37
ERADICATE, NCT04484818: Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The Study

Active, not recruiting
3
27
US
Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, ODM 201, ODM-201, Goserelin Acetate, ZDX, Zoladex, Leuprolide Acetate, A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Lutrate, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Detryptoreline
ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)
Prostate Carcinoma
12/25
05/28
CARE, NCT05771896: Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Withdrawn
3
514
NA
Darolutamide, Nubeqa, Radium-223, Xofigo
GenesisCare USA, Bayer
Metastatic Prostate Cancer
12/28
04/29
A Phase III study comparing darolutamide plus ADT versus placebo plus ADT in high-risk BCR patients, ChiCTR2400082864:

Not yet recruiting
3
750
 
Placebo plus ADT; Darolutamide plus ADT
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Bayer Consumer Care AG
Hormone-sensitive prostate cancer is at high risk for biochemical recurrence
 
 
GUIDANCE, NCT05050084: Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Recruiting
3
2050
Canada, US
Bicalutamide, Casodex, Cassotide, Cosudex, ICI 176,334, ICI 176334, Utamide, Buserelin, 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig), BSRL, Busereline, Etilamide, HOE 766, HOE-766, HOE766, ICI 123215, ICI-123215, ICI123215, S74 6766, S74-6766, S746766, Tiloryth, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, ODM201, Degarelix, ASP 3550, ASP-3550, ASP3550, FE 200486, FE-200486, FE200486, Firmagon, Flutamide, 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, Sch 13521, Tafenil, Tecnoflut, Testotard, Goserelin, ICI-118630, Histrelin, Leuprolide, Leuprorelin, Radiation Therapy, Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Relugolix, N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385, Triptorelin, 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY 25650, AY-25650, AY25650, CL 118532, CL-118,532, CL-118532, CL118532, Detryptoreline
NRG Oncology, National Cancer Institute (NCI)
Prostate Adenocarcinoma
11/26
11/26
THUNDER, NCT06282588: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting
2/3
493
Europe
Darolutamide, Nubeqa, BAY1841788, Darolutamide matched placebo, BAY1841788 matched placebo, Radiotherapy, Zoladex 3.6Mg Implant, Goserelin acetate 3.6 mg, Zoladex LA, Goserelin acetate 10.8 mg, Decapeptyl sustained release 22.5 mg, Triptorelin 11.25 mg, Decapeptyl sustained release 11.25 mg, Depo-Eligard 45 mg, Leuprorelin acetate 45 mg, Depo-Eligard 22.5 mg, Leuprorelin acetate 22.5 mg, Depo-Eligard 7.5 mg, Leuprorelin acetate 7.5 mg, Firmagon 120 MG Injection, Degarelix 40 mg, Firmagon 80 MG Injection, Degarelix 20 mg, Docetaxel, Taxotere
Cancer Research Antwerp, Bayer, Veracyte, Inc.
Prostate Cancer
07/30
12/30
ACTRN12623000160639: A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)

Not yet recruiting
2
32
 
St Vincent's Hospital Sydney, St Vincent's Hospital Sydney
Prostate cancer
 
 
ACTRN12624001458527: A study of opaganib in addition to darolutamide in participants with metastatic hormone resistant prostate cancer, selected for the presence of a specific biomarker.

Not yet recruiting
2
60
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Ramsay Foundation , Bayer Australia Limited
Prostate Cancer
 
 
ACTRN12624000582550: Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide.

Recruiting
2
69
 
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer
Prostate Cancer
 
 
2019-004952-13: Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART)

Not yet recruiting
2
140
Europe
ODM-201, BAY1841788, Film-coated tablet, NUBEQA
University Hospital Ghent, Bayer Consumer Care AG
- Prostate cancer patients with a biochemical recurrence following primary therapy- Hormone-sensitive- Up to 5 metastases on PSMA PET-CT, Prostate Cancer, Diseases [C] - Cancer [C04]
 
 
SAKK 08/16, NCT02933801 / 2016-003996-23: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

Terminated
2
92
Europe
ODM-201, BAY-1841788, Placebo
Swiss Group for Clinical Cancer Research
Prostate Cancer Metastatic, Prostate Cancer
06/21
11/23
2020-000823-38: Study on the interaction between cabazitaxel and darolutamide in patients with metastatic prostate cancer Studie naar de wisselwerking tussen cabazitaxel en darolutamide bij patiënten met uitgezaaide prostaatkanker

Not yet recruiting
2
17
Europe
Tablet, Infusion, darolutamide, Cabazitaxel
Erasmus MC Cancer Institute, Erasmus MC Cancer Institute
metastatic castration-resistant prostate cancer Gemetastaseerde castratie-resistente prostaatkanker, Prostate cancer spread to other parts of the body Uitgezaaide prostaatkanker, Diseases [C] - Cancer [C04]
 
 
ODENZA, NCT03314324 / 2017-001606-14: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

Active, not recruiting
2
250
Europe
ODM-201, Enzalutamide
Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Castrate-resistant Prostate (CRPC) Cancer
01/22
10/24
2022-002431-53: A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER DAROLUTAMIDE (ODM-201) CONCOMITANT A LA RADIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER DE LA PROSTATE A RISQUE INTERMEDIAIRE DEFAVORABLE : UNE ETUDE MULTICENTRIQUE RANDOMISEE NON-COMPARATIVE DE PHASE II

Ongoing
2
62
Europe
DAROLUTAMIDE, Dégarélix, Goséréline, Leuproréline, Triptoréline, RADIOTHERAPY, Tablet, Powder and solvent for solution for injection, Implant in pre-filled syringe, , NUBEQA, FIRMAGON, ZOLADEX, ELIGARD, ENANTONE, DECAPEPTYL, GONAPEPTYL, RADIOTHERAPY
Institut Bergonié, Bayer Healthcare SAS
Prostate cancer Cancer de la prostate, Intermediate unfavorable risk prostate cancer Cancer de la prostate à risque intermédiaire défavorable, Diseases [C] - Cancer [C04]
 
 
NCT05249712: Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Recruiting
2
30
RoW
Darolutamide 300 mg, Nubeqa, BAY1841788, Androgen deprivation therapy, ADT
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University
Prostate Cancer
01/23
12/25
2022-003792-41: Chemotherapy with or without darolutamide in men with metastatic prostate cancer.

Not yet recruiting
2
245
Europe
Nubeqa, Tablet, Nubeqa/Darolutamide
Erasmus MC, Bayer
metastatic castration-resistant prostate cancer, Prostate cancer spread to other parts of the body, Diseases [C] - Cancer [C04]
 
 
NCT06173362: Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting
2
75
US
Abiraterone, CB 7598, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Mamta Parikh, National Cancer Institute (NCI)
Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
11/26
05/27
 

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