Monofer (iron isomaltoside 1000) / Pharmacosmos  >>  Phase 4
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25 Trials

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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

Completed
4
1000
RoW
Ferric carboxymaltose, ferinject, Iron isomaltoside, Placebo, No active drug
Bayside Health, National Health and Medical Research Council, Australia, Monash University
Anaemia
04/24
09/24
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

Recruiting
4
94
Europe
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
ChiCTR2400083168: Application Study of Iron Isomaltoside in Patients with Iron Deficiency Anemia Six Months After Weight Loss Surgery

Not yet recruiting
4
200
 
Iron isomaltoside injection (MonoFer), administered by intravenous drip, referring to the simplified scale method of administration in the product insert. Note: The maximum single dose of ferric isomaltoside is 20 mg/kg, and according to the simplified scale, a second infusion is required every other week if a single underdose is made up.; Iron Polysaccharide Complex (NIFEREX), 150mg/day for 8 weeks by oral
The Third People's Hospital of Chengdu; Bethune Foundation, Bethune Foundation
Iron Deficiency Anemia After Weight Loss Surgery
 
 
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

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