| Monofer (iron isomaltoside 1000) / Pharmacosmos |
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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. |
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| 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) |
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| 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 |
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| 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 |
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| Recruiting | 4 | 214 | RoW | Normal saline, Iron isomaltoside | Yonsei University | Aortic Stenosis (Treated With TAVI) | 03/23 | 03/23 | | |
| 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 |
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| 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 |
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| 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] | | | | |
| 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 |
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| Recruiting | 4 | 452 | RoW | Niferex, MonoFer | Qianfoshan Hospital | Iron Deficiency Anemia of Pregnancy, Iron Storage Disease | 01/24 | 01/25 | | |
| 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 | | |
| 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 |
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| 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 |
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| 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 |
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| 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 | | | | |
| 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 |
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| 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 |
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| 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 | | | | |
| 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 |
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| 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 |
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| 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 |
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| 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. |
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| 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 |
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| 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 |
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| 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 |
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| 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 | 03/25 | 04/25 | | |
IIOVS-01, NCT06248749: Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer |
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| 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 |
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| Recruiting | 3 | 200 | US | Ferric Derisomaltose, Monofer®, Monoferric® | Pharmacosmos A/S | Iron Deficiency, Anaemia in Children | 04/25 | 06/25 | | |
2024-000321-41: A phase III, prospective, open-label, multi-center trial of ferric derisomaltose in children 0 to <18 years of age with iron deficiency anemia due to non-dialysis dependent chronic kidney disease or with iron deficiency anemia who are intolerant or unresponsive to oral iron. |
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| Not yet recruiting | 3 | 200 | US | Monoferric, Solution for injection/infusion, Monoferric | Pharmacosmos A/S, Pharmacosmos A/S | Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
NCT05407987: Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) |
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| Not yet recruiting | 3 | 82 | Canada | Ferric derisomaltose, MONOFERRIC, Placebo | AHS Cancer Control Alberta | Gynecologic Cancer, Anemia, Iron-deficiency | 09/25 | 12/25 | | |
| 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 | | |
| 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 |
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| 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. |
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| 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 |
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| 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 | | |
NCT05913414: Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma |
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| 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 | | |
POAM, NCT06287619: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery |
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| 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 | 12/25 | 06/26 | | |
| 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 |
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| 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 (). |
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| Completed | N/A | 327 | Europe | Iron isomaltoside 1000, Iron Derisomaltose 1000 | Pierre Fabre Pharma AG | Iron-Deficiency Anemia, Iron-Deficiency | 11/22 | 11/22 | | |
| 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 |
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| 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 | | |
| 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 | | |
| 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 |
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| 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 | | | | |
| 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 | | | | |
ChiCTR2400090696: Effect of preoperative combination of low-dose dexamethasone with iron isomaltoside on prognosis of elderly intertrochanteric hip fractures ---- Single-center, randomized, single-blind, blank controlled clinical trial |
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| Not yet recruiting | N/A | 160 | | Traditional ERAS, 250ml normal saline +10ml (1000mg Fe) iron isomaltoside injection was administered at admission, and 2ml (10mg) dexamethasone was in; Traditional ERAS | Guabgzhou First People‘s Hospital; Guabgzhou First People‘s Hospital, Guangzhou area clinical high-tech, major and characteristic technology projects | intertrochanteric hip fracture | | | | |
