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Clinical trials for Ferric Carboxymaltose (FCM)

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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   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).

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    28 result(s) found for: Ferric Carboxymaltose (FCM). Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-001664-22 Sponsor Protocol Number: 2011-001664-22 Start Date*: 2011-12-22
    Sponsor Name:Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
    Full Title: A prospective, randomized, multicenter study to evaluate the impact of Darbepoetin alfa in combination with Ferric(III)-Carboxymaltose in comparison to Darbepoetin alfa and Ferric(III)-Carboxymalto...
    Medical condition: This is a prospective, multicenter, randomized, comparative, parallel group, phase IV study to assess the efficacy and safety of FCM 800mg or Darbepoetin alfa 500µg or the combination of FCM 800mg ...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-017737-21 Sponsor Protocol Number: IDNA 2009-01 Start Date*: 2011-01-18
    Sponsor Name:Vifor Pharma
    Full Title: A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose (1,000 mg iron) in Improving Fatigue Symptoms in Iron-deficie...
    Medical condition: Treatment of iron deficient non anaemic women with ferric carboxymaltose.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022970 Iron deficiency LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) AT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003821-70 Sponsor Protocol Number: 1VIT18045 Start Date*: Information not available in EudraCT
    Sponsor Name:American Regent, Inc.
    Full Title: Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
    Medical condition: Iron Deficiency Anemia (IDA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001695-19 Sponsor Protocol Number: FER-CARS-05 Start Date*: 2011-12-22
    Sponsor Name:Vifor (International) Inc.
    Full Title: A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose with Placebo in Patients with Chronic Heart Failure and Iron Deficiency
    Medical condition: Iron deficiency in patients with chronic heart failure
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10008908 Chronic heart failure LLT
    14.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed) DE (Completed) SE (Completed) GB (Completed) IE (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015579-28 Sponsor Protocol Number: FER-CKD-01 Start Date*: 2009-12-22
    Sponsor Name:Vifor Pharma Inc.
    Full Title: An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Ir...
    Medical condition: Iron deficiency anaemia in subjects with non-dialysis-dependent chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    14.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) SE (Completed) FR (Completed) DE (Completed) DK (Completed) ES (Completed) IT (Completed) CZ (Completed) AT (Completed) GR (Completed) PT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000603-40 Sponsor Protocol Number: FER-CARS-04 Start Date*: 2011-06-20
    Sponsor Name:Vifor (International) Inc.
    Full Title: Multicentre, prospective, randomised, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency
    Medical condition: Iron deficiency in patients with chronic heart failure
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004849 10008908 Chronic heart failure LLT
    14.1 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-000574-30 Sponsor Protocol Number: VIT-RLS-2012-013 Start Date*: 2013-09-23
    Sponsor Name:Vifor (International) Inc.
    Full Title: A Randomised, Assessor- and Patient-blind, Multicentre, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Outcomes in Iron ...
    Medical condition: Non-anaemic iron deficient patients with restless legs syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-002956-20 Sponsor Protocol Number: FerinjectFPG2020 Start Date*: 2021-01-19
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.
    Medical condition: This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10050308 Iron replacement LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003858-85 Sponsor Protocol Number: HFIRONT Start Date*: 2020-02-24
    Sponsor Name:Medical University Innsbruck
    Full Title: Randomized double-blind explorative controlled clinical trial analyzing the effects of ferric carboxymaltose in patients with iron deficiency and chronic heart failure
    Medical condition: This is a randomized double-blind explorative controlled clinical Trial that analyses the effects of 1000mg ferric carboxymaltose in patients with chronic heart failure and iron deficiency.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002078-27 Sponsor Protocol Number: 1VIT17044 Start Date*: 2019-02-12
    Sponsor Name:American Regent, Inc.
    Full Title: A Multicenter, Multinational, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia
    Medical condition: Iron Deficiency Anemia (IDA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005224-18 Sponsor Protocol Number: CLEVER-2011 Start Date*: 2012-04-26
    Sponsor Name:GWT-TUD GmbH
    Full Title: Intravenous Ferric Carboxymaltose for improvement of metabolic parameters and vascular function in T2DM patients with iron deficiency
    Medical condition: patients with diabetes mellitus type 2 and iron deficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002571-18 Sponsor Protocol Number: 170KG18 Start Date*: 2019-07-22
    Sponsor Name:University Medical Center Groningen
    Full Title: EFFECT OF FERRIC CARBOXYMALTOSE ON EXERCISE CAPACITY AFTER KIDNEY TRANSPLANTATION: A MULTICENTER RANDOMIZED CONTROLLED TRIAL
    Medical condition: Iron deficiency in kidney transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10022971 Iron deficiencies HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015767-14 Sponsor Protocol Number: FER-FID-CHEMO Start Date*: Information not available in EudraCT
    Sponsor Name:Vifor (International) AG
    Full Title: A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with lymphoid malignancies...
    Medical condition: Anaemic subjects with lymphoid malignancies and functional iron deficiency receiving chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025631 Malignant lymphoid neoplasm NOS LLT
    14.0 10005329 - Blood and lymphatic system disorders 10002034 Anaemia PT
    14.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002021-11 Sponsor Protocol Number: 1VIT14039 Start Date*: 2016-07-13
    Sponsor Name:Luitpold Pharmaceuticals, Inc.
    Full Title: IRON CLAD: Can Iron Lessen Anemia Due to cancer and chemotherapy: A multicenter, randomized, double-blinded, controlled study to investigate the efficacy and safety of Injectafer® (ferric carboxyma...
    Medical condition: cancer- and chemotherapy-related anemia
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004851 10002272 Anemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000068-40 Sponsor Protocol Number: FAIR-HF2 Start Date*: 2017-01-27
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Intravenous iron in patients with systolic heart failure and iron deficiency to improve morbidity & mortality. Ferric carboxymaltose Assessment of morbidity and mortality in patients with IRon de...
    Medical condition: Systolic heart failure associated with iron deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10074631 Systolic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PT (Completed) SI (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000831-41 Sponsor Protocol Number: AMAG-FER-IDA-304 Start Date*: 2016-06-09
    Sponsor Name:AMAG Pharmaceuticals, Inc.
    Full Title: A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
    Medical condition: Iron deficiency anemia (IDA)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004851 10022975 Iron deficiency anemia secondary to blood loss (chronic) LLT
    18.1 100000004851 10022976 Iron deficiency anemia secondary to inadequate dietary iron intake LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) LV (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-017658-11 Sponsor Protocol Number: FER-ASAP-2009-01 Start Date*: 2010-05-03
    Sponsor Name:Vifor Pharma
    Full Title: An open-label, multicentre, randomised, 2-arm study to investigate the comparative efficacy and safety of intravenous ferric carboxymaltose versus oral iron for the treatment of iron deficiency ana...
    Medical condition: Iron deficiency anaemia in pregnant woman
    Disease: Version SOC Term Classification Code Term Level
    17.1 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001467-36 Sponsor Protocol Number: FER-CARS-06 Start Date*: 2017-02-02
    Sponsor Name:Vifor (International) Inc.
    Full Title: A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart F...
    Medical condition: Acute heart failure with iron deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007541 Cardiac disorders SOC
    20.0 100000011689 10000803 Acute heart failure LLT
    20.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) PL (Completed) HR (Completed) SE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002912-25 Sponsor Protocol Number: 1VIT15043 Start Date*: 2019-11-18
    Sponsor Name:American Regent, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
    Medical condition: Heart Failure with Iron Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) HU (Completed) CZ (Completed) LT (Completed) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002496-26 Sponsor Protocol Number: ST10-01-304 Start Date*: 2015-12-02
    Sponsor Name:Shield TX (UK) Ltd.
    Full Title: A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects w...
    Medical condition: Iron deficiency anaemia with inflammatory bowel disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002062 Anaemia iron deficiency LLT
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) HU (Completed)
    Trial results: View results
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