Monofer (iron isomaltoside 1000) / Pharmacosmos 
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48 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Monofer (iron isomaltoside 1000) / Pharmacosmos
2010-020452-64: Iron treatment in patients with known kidney disease

Ongoing
4
100
Europe
COSMOFER, VENOFER, MONOFER, B03AB04, , Solution for infusion in administration system, COSMOFER, VENOFER, MOnofer
Hull and East Yorkshire Hospitals NHS Trust
patients with known chonic kidney disease with functional or absolute Iron deficiency Anaemia, and are greater than 18 years will be given repleacement iron therapy accoring to current local protocols and NICE guidelines
 
 
2013-004979-13: A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal Cavity Et placebokontrolleret lodtrækningsforsøg med intravenøst jern til behandling af lav blodprocent før operation hos patienter med kræft i nyre, blære eller bagerst i bugvæggen

Ongoing
4
84
Europe
Monofer, Monofer, Monofer
Rigshospitalet, 2032, Pharmacosmos A/S
Iron deficiency anaemia and anaemia of chronic disease Jernmangelanæmi og anæmi ved kronisk sygdom
 
 
2016-004439-19: Intravenous iron for treatment of anaemia before cardiac surgery

Ongoing
4
1000
Europe
Iron(III) isomaltoside 1000 (Monofer), Solution for injection/infusion, Iron(III) isomaltoside 1000 (Monofer)
Alfred Health, National Health and Medical Research Council
Anaemia, Anaemia, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2018-001669-17: ICaRAS - A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care

Ongoing
4
40
Europe
Iron Isomaltoside 100mg in 1ml solution for infusion, Solution for infusion, Iron Isomaltoside 100mg in 1ml solution for infusion
Nottingham University Hospitals NHS Trust, NIHR - Research for Patient Benefit
Iron deficiency anaemia secondary to cancer, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-004370-26: Intravenous Iron Products and Phosphaturia in patients with Chronic Kidney Disease

Not yet recruiting
4
30
Europe
Monofer, Ferinject, Solution for injection/infusion, Solution for injection, Monofer, Ferinject
Hull University Teaching Hospitals NHS Trust, Pharmacosmos A/S
Iron deficiency anaemia associated with Chronic Kidney Disease, Anaemia because of low iron associated with chronic kidney disease, Body processes [G] - Metabolic Phenomena [G03]
 
 
2019-002661-35: FERRIC-CABG: Effect of Iron Isomaltoside in Patients Undergoing CoronaryArtery Bypass Grafting +/- Valve Surgery.

Not yet recruiting
4
240
Europe
Solution for injection/infusion, MONOFER
King's College London, King's College Hospital NHS Foundation Trust, British Heart Foundation
Coronary or heart valve disease needing cardiac surgery, Coronary or heart valve disease needing cardiac surgery, Diseases [C] - Cardiovascular Diseases [C14]
 
 
2021-005383-22: Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)

Not yet recruiting
4
36
Europe
MonoFer 100 mg/ml, Solution for infusion, MonoFer 100 mg/ml
Universitätsmedizin Göttingen, Pharmacosmos A/S
Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Diseases [C] - Cardiovascular Diseases [C14]
 
 
IVIronPPH, NCT04505514: Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

Recruiting
4
60
RoW
Iron Isomaltoside 1000, Placebo, Iberet-Folic-500
University of Malaya
Post Partum Hemorrhage, Anemia
10/22
12/22
NCT04346004: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

Recruiting
4
214
RoW
Normal saline, Iron isomaltoside
Yonsei University
Aortic Stenosis (Treated With TAVI)
03/23
03/23
NCT05258825: Preoperative Monoferric for Abdominal Surgery

Not yet recruiting
4
32
US
Monoferric
Brigham and Women's Hospital, Pharmacosmos A/S
Anemia, Surgery
03/23
04/23
PICS, NCT04608539: A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery

Completed
4
110
Europe
Ferric Derisomaltose, MonoFer, iron isomaltoside 1000, Ferrous sulfate, Ferro Duretter, normal saline, 0.9% natriumchloride
Michael Kremke, Aarhus University Hospital, University of Aarhus, Pharmacosmos A/S
Anemia Postoperative
06/23
06/23
2020-001389-12: Intravenous iron for the treatment of anaemia following cardiac surgery

Not yet recruiting
4
110
Europe
Solution for injection, Tablet, MonoFer, Ferro Duretter
Aarhus University Hospital, Aarhus University Hospital, Aarhus, Pharmacosmos A/S, Holbæk
Anaemia following cardiac surgery, Anaemia following cardiac surgery, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ITACS, NCT02632760: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

Recruiting
4
1000
RoW
Ferric carboxymaltose, ferinject, Iron isomaltoside, Placebo, No active drug
Bayside Health, National Health and Medical Research Council, Australia, Monash University
Anaemia
12/23
06/24
NCT05804071: Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy

Recruiting
4
452
RoW
Niferex, MonoFer
Qianfoshan Hospital
Iron Deficiency Anemia of Pregnancy, Iron Storage Disease
01/24
01/25
RAPIDIRON, NCT05358509: Reducing Anemia in Pregnancy in India: the Trial

Completed
4
4368
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Children's Investment Fund Foundation, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences, Sawai Mansingh Medical College
Iron Deficiency Anemia, Infant, Low Birth Weight, Anemia of Pregnancy
12/23
01/24
IVORY, NCT06350955: IV Iron-induced Hypophosphatemia After RYGB

Not yet recruiting
4
94
NA
Iron isomaltoside, Iron Carboxymaltose
Lucie Favre
Hypophosphatemia, Roux-en-Y Gastric Bypass
06/26
06/26
COREVIVE-HFrEF, NCT05971732: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
146
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Reduced Ejection Fraction, Iron Deficiency, Acute Heart Failure
08/24
08/25
COREVIVE-HFpEF, NCT05991128: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
170
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies, Acute Heart Failure
08/24
08/25
ChiCTR2300074150: Efficacy and Safety of Monofer (Iron Isomaltate) in the Treatment of postoperative anemia in patients with Spinal Metastasis: a Randomized, controlled, open-label Clinical trial

Not yet recruiting
4
92
 
Iron isomaltoside on the third postoperative day (according to the recommendations of the drug manufacturer), and the maximum dose of iron isomaltoside was limited to 20mg/Kg. ;Ferrous succinate tablets 200mg bid on the third day after operation, a total of 400mg per day, continuous oral administration for 28 days.
Shanghai Changzheng Hospital; Shanghai Changzheng Hospital, Cosmos Pharmaceutical Technology (Beijing) Co., Ltd.
spinal metastases patients with iron deficiency anemia after operation
 
 
IRONMETHFpEF, NCT04945707: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Recruiting
4
66
US
Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric], Monoferric, Placebo, Normal Saline
Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Pharmacosmos A/S, National Institutes of Health (NIH)
Iron-deficiency, Heart Failure With Preserved Ejection Fraction
02/25
05/25
NCT05714007: The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

Recruiting
4
120
RoW
Ferric derisomaltose, MONOFER®, Ferrous succinate
Peking Union Medical College Hospital, Pharmacosmos A/S
Perioperative Anemia, Surgery, Spinal Deformity, Adult
06/25
06/25
ChiCTR2300072661: Comparison of clinical outcome and pharmacoeconomics of high-dose intravenous iron(Iron Isomaltoside Injection) and oral iron in that treatment of iron deficiency anemia

Recruiting
4
312
 
Use of iron isomaltose on a simplified scale, intravenous infusion over 15 minutes ;Polysaccharide iron complex 0.3g was used once a day for 4 months after hemoglobin returned to normal.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Bethune Foundation
Iron Deficiency Anemia
 
 
AGE-ANEMIA, NCT04913649: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Recruiting
4
310
Europe
Ferric Derisomaltose 100 MG/ML, Monofer, Sodium chloride, Placebo
dr. P. Noordzij, Pharmacosmos A/S
Iron Deficiency Anemia
09/25
12/25
NCT05719376: The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes

Not yet recruiting
4
302
RoW
Monofer (experimental), control group
Yonsei University
Kidney Failure, Chronic
05/26
06/26
2016-003087-40: Interest of intraveinous iron and tranexamic acid to reduce transfusion in hip fracture patients - HIFIT Study Intérêt du fer intraveineux et de l'acide tranexamique dans la réduction transfusionnelle chez les patients souffrant d'une fracture du col du fémur - Etude HIFIT

Not yet recruiting
3
780
Europe
MONOFER, EXACYL 500mg-5mL, Solution for injection, MONOFER 1000mg-10mL, EXACYL 500mg-5mL
UHangers, UHAngers
Hip fracture Fracture du col du fémur, Hip Fracture Fracture du col du fémur, Body processes [G] - Bones and nerves physological processes [G11]
 
 
2019-004583-22: Evaluation of positive effects of iron treatment for patients with the restless legs syndrome, who either received dopaminergic therapy before or not.

Not yet recruiting
3
140
Europe
Infusion, Monofer 100mg/ml Lösung zur Injektion und Infusion
Medical University of Innsbruck, Medical University of Innsbruck
Restless leg syndorme, Restless leg syndrome, Not possible to specify
 
 
NCT05251493: Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Recruiting
3
280
Canada
Iron Isomaltoside 1000, ferric derisomaltose, Monoferric DIN 22477777, Iron sucrose, iron sucrose DIN 02502917
Saskatchewan Health Authority - Regina Area, Saskatchewan Centre for Patient-Oriented Research
Iron Deficiency Anaemia in Childbirth
12/24
02/25
FORGE, NCT05467319: Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

Not yet recruiting
3
82
NA
Ferric Derisomaltose Injection, iron isomaltoside, Monoferric, Monofer, Normal saline
Alberta Health Services, Calgary, Pharmacosmos A/S
Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
09/23
12/23
NCT05304442: IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Recruiting
3
40
US
Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric], Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Baylor College of Medicine, Pharmacosmos Therapeutics, Inc.
Anemia, Iron Deficiency, Uterine Bleeding
10/24
10/24
IIOVS-01, NCT06248749: Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer

Not yet recruiting
3
200
Canada
IV iron, iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)
University of Saskatchewan
Anaemia in Ovarian Carcinoma
12/28
12/29
NCT05179226: Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Recruiting
3
200
US
Ferric Derisomaltose, Monofer®, Monoferric®
Pharmacosmos A/S
Iron Deficiency, Anaemia in Children
04/24
06/24
NCT05407987: Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Not yet recruiting
3
82
Canada
Ferric derisomaltose, MONOFERRIC, Placebo
AHS Cancer Control Alberta
Gynecologic Cancer, Anemia, Iron-deficiency
09/25
12/25
IVIDA2, NCT05462704: Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Recruiting
3
746
US
Ferric derisomaltose, Monoferric, Ferrous sulfate, Ferosul
Women and Infants Hospital of Rhode Island, Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine
Iron Deficiency Anemia, Pregnancy
03/27
03/27
2014-004133-16: The Iron and Heart Trial

Ongoing
2
84
Europe
Monofer 100mg/ml, Solution for infusion in administration system, Monofer
Hull and east Yorkshire Hospitals Trust, Kidney Research UK
Chronic Kidney Disease stages 3b to 5 with iron deficiency, Chronic Kidney Disease
 
 
2019-002037-11: Intravenous iron supplement for patients with severe aortic stenosis who have iron deficiency

Not yet recruiting
2
100
Europe
Monofer, Infusion, Monofer
Oslo University Hospital, Pharmacosmos
Iron deficiency, aortic stenosis, Iron deficeincy, aortic valve narrowing, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
2019-003819-56: Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. Effekterne af intravenøs jern hos patienter med tyk- og endetarmskræft og jernmangel, men ikke med lav blodprocent.

Not yet recruiting
2
134
Europe
Monofer, B03AC, Infusion, Monofer
Centre for Surgical Science, Pharmacosmos
Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Diseases [C] - Cancer [C04]
 
 
IIISAS, NCT04206228: Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Active, not recruiting
2
149
Europe
Intravenous iron isomaltoside, Monofer®, Placebo, Intravenous sodium chloride 0.9%
Oslo University Hospital
Severe Aortic Stenosis, Iron-deficiency
03/22
03/23
POAM, NCT06287619: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

Not yet recruiting
2
60
Canada
Monoferric Injectable Product, Ferric derisomaltose, 0.9% sodium chloride solution
University Health Network, Toronto, Queen's University, Sunnybrook Health Sciences Centre, Heart and Stroke Foundation of Canada
Chronic Iron Deficiency Anaemia, Cardiac Surgery
12/24
06/25
NCT05913414: Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Recruiting
2
120
RoW
Iron Isomaltoside 1000, Iron isomaltoside, Polysaccharide Iron Complex Pill, Intensity-modulated radiotherapy
Sun Yat-sen University
Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
05/24
05/26
NCT05763043: Monoferric for Prenatal Iron Deficiency

Not yet recruiting
1
80
US
Ferric derisomaltose, Monoferric
Oregon Health and Science University
Obstetric Labor Complications
10/28
10/28
ChiCTR1800017010: Efficacy of preoperative intravenous iron isomaltoside in colorectal cancer surgical patients with iron deficiency anaemia compared to standard care: a pilot randomized controlled trial

Recruiting
N/A
40
 
Iron Isomaltoside 1000 Inj. (100mg/ml and 500mg/5mls), Intravenous infusion 20mg/kg (<50kg BW) or 1000mg (>50kg BW) single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation) versus Standard care(control) - no iron supplement
Department of Anaesthesia and Intensive Care, PWH; Department of Surgery, PWH, Prince of Wales Hospital, Hospital Authority
Iron deficiency anaemia; Colorectal cancer
 
 
Real-CHOICE, NCT04318405: Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery ().

Completed
N/A
327
Europe
Iron isomaltoside 1000, Iron Derisomaltose 1000
Pierre Fabre Pharma AG
Iron-Deficiency Anemia, Iron-Deficiency
11/22
11/22
NCT05545527: Neuroimaging Ancillary Study

Active, not recruiting
N/A
184
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College
Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus, Iron Deficiency Anemia Treatment, Fetal Neurodevelopmental Disorder, Child Development
02/24
02/25
Hematoboost, NCT05911438: Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia

Not yet recruiting
N/A
419
RoW
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO), Basic Treatment
West China Hospital
Total Knee Arthroplasty
12/24
06/25
RAPIDIRON-KIDS, NCT05504863: RAPIDIRON Trial Follow-up Study: Study

Active, not recruiting
N/A
538
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences
Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum Disorder
01/25
01/26
OVI-IBD, NCT05581420: Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

Recruiting
N/A
152
Europe
Ferrous fumarate, MonoFer, Ferinject, Cosmofer, Venofer
Leiden University Medical Center, University Medical Center Groningen, UMC Utrecht, Rijnstate Hospital, Erasmus Medical Center, Sint Franciscus Gasthuis, Adrz, Goes, Medical Center Haaglanden
Inflammatory Bowel Diseases
05/25
05/25
ChiCTR2200066959: Study on the effect of iron supplementation on the efficacy of anti-TNF-α monoclonal antibody in patients with IBD

Not yet recruiting
N/A
200
 
iron isomaltoside ;Without intervention
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 
Comparative iron treatment for patients with IBD and IDA, ChiCTR2200066056: A comparative study of iron isomaltoside versus traditional iron supplements in patients with inflammatory bowel diseases and iron deficiency anemia

Not yet recruiting
N/A
200
 
iron isomaltoside ;traditional iron supplements
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 

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