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Clinical trials for monofer

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    33 result(s) found for: monofer. Displaying page 2 of 2.
    « Previous 1  2 
    EudraCT Number: 2011-003695-36 Sponsor Protocol Number: Start Date*: 2012-09-07
    Sponsor Name:Brighton & Sussex University Hospitals NHS Trust
    Full Title: Is intravenous iron and darbepoetin more effective than oral iron in reducing blood transfusion requirements for patients undergoing cardiac surgery
    Medical condition: Anaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10066761 Acute anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004370-26 Sponsor Protocol Number: R2451 Start Date*: 2020-02-14
    Sponsor Name:Hull University Teaching Hospitals NHS Trust
    Full Title: Exploratory single centre prospective 12-week comparative double blinded randomised trial of the impact of high-dose iron isomaltoside vs iron carboxymaltose on measures of FGF23, bone metabolism a...
    Medical condition: Iron deficiency anaemia associated with Chronic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    21.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    20.0 10005329 - Blood and lymphatic system disorders 10066763 Chronic iron deficiency anaemia LLT
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    20.0 10005329 - Blood and lymphatic system disorders 10055738 Iron deficiency anaemia, unspecified LLT
    20.1 10022891 - Investigations 10072681 Fibroblast growth factor 23 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003087-40 Sponsor Protocol Number: PHRC-N-2015 Start Date*: 2017-01-17
    Sponsor Name:UHangers
    Full Title: Interest of intraveinous iron and tranexamic acid to reduce transfusion in hip fracture patients - HIFIT Study
    Medical condition: Hip fracture
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-004979-13 Sponsor Protocol Number: 2012-496 Start Date*: 2014-01-29
    Sponsor Name:Rigshospitalet, 2032
    Full Title: Treatment of Preoperative Anaemia in Patients with Urogenital Cancer: A Randomised Double-Blind Placebo-Controlled Study of Intravenous Iron Isomaltide 1000 Monofer© versus Saline
    Medical condition: Iron deficiency anaemia and anaemia of chronic disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004851 10022974 Iron deficiency anemia LLT
    17.1 100000004851 10020970 Hypochromic anaemia of chronic disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004439-19 Sponsor Protocol Number: 16/0099 Start Date*: 2017-06-01
    Sponsor Name:Alfred Health
    Full Title: IV iron for Treatment of Anaemia before Cardiac Surgery
    Medical condition: Anaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2024-000321-41 Sponsor Protocol Number: P-Monofer-PED-01 Start Date*: 2024-10-15
    Sponsor Name:Pharmacosmos A/S
    Full Title: 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 o...
    Medical condition: Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-020452-64 Sponsor Protocol Number: version2.0 Start Date*: 2010-10-05
    Sponsor Name:Hull and East Yorkshire Hospitals NHS Trust
    Full Title: A prospective randomisd open label study to determine the effects of intravenous iron administration on markers of acute kidney injury in chronic kidney disease (CKD)
    Medical condition: 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 protoc...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10005329 - Blood and lymphatic system disorders 10022973 Iron deficiency anaemias LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000765-37 Sponsor Protocol Number: P-CKD-01 Start Date*: 2007-05-10
    Sponsor Name:Pharmacosmos A/S
    Full Title: A non-comparative open-label study of Iron Oligosaccharide in Chronic Kidney Disease patients with a need for parenteral iron
    Medical condition: Patients with Chronic kidney disease who are in pre-dialysis or undergoing dialysis (either Peritoneal Dialysis or Haemodialysis), who may be treated with erythropoeisis stimulating agents and have...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002062 Anaemia iron deficiency LLT
    9.1 10018875 Haemodialysis LLT
    9.1 10061105 Dialysis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-005592-13 Sponsor Protocol Number: FERRICHFII Start Date*: 2014-02-27
    Sponsor Name:King's College London [...]
    1. King's College London
    2. King's College Hospital NHS Foundation Trust
    Full Title: Mechanisms of Exercise Benefit with Intravenous Iron in Chronic Heart Failure: The Ferric Iron in Heart Failure (FERRIC HF) II Trial
    Medical condition: Chronic Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002661-35 Sponsor Protocol Number: FERRICCABG01 Start Date*: 2020-04-23
    Sponsor Name:King's College London [...]
    1. King's College London
    2. King's College Hospital NHS Foundation Trust
    Full Title: Effect of Iron Isomaltoside on Perioperative Myocardial Injury in Patients Undergoing Coronary Artery Bypass Graft ± Valve Surgery: The Ferric Iron in Coronary Artery Bypass Grafting (FERRIC-CABG) ...
    Medical condition: Coronary or heart valve disease needing cardiac surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10068617 Coronary heart disease LLT
    20.0 100000004849 10019316 Heart valve disorders LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-000764-25 Sponsor Protocol Number: P-CHF-01 Start Date*: 2007-05-10
    Sponsor Name:Pharmacosmos A/S
    Full Title: A non-comparative open-label study of Iron Oligosaccharide in CHF patients with iron deficiency (either absolute or functional) anaemia and a need for parenteral iron.
    Medical condition: Patients with anaemia and who have a need for parenteral iron due to either absolute or functional iron deficiency anaemia will be included. Patients may receive concomitant Erythropoeisis Stimulat...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002062 Anaemia iron deficiency LLT
    9.1 10010684 Congestive heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-001389-12 Sponsor Protocol Number: PICS1.0 Start Date*: 2020-10-29
    Sponsor Name:Aarhus University Hospital
    Full Title: The Postoperative Iron in Cardiac Surgery (PICS-) trial: A randomised clinical trial comparing the efficacy of single-, high-dose intravenous iron and oral iron for the treatment of anaemia followi...
    Medical condition: Anaemia following cardiac surgery
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004851 10057220 Acute post haemorrhagic anaemia LLT
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-000894-16 Sponsor Protocol Number: NL79105.058.22 Start Date*: 2022-05-04
    Sponsor Name:Leiden University Medical Center
    Full Title: Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease
    Medical condition: Inflammatory Bowel Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    20.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    20.1 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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