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Clinical trials for Epoetin alfa

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    70 result(s) found for: Epoetin alfa. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2013-001497-16 Sponsor Protocol Number: 1517-CL-0613 Start Date*: 2014-11-05
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dia...
    Medical condition: Anemia in End Stage Renal Disease (ESRD) subjects on stable dialysis.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012844 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) BE (Completed) PT (Completed) HU (Completed) ES (Completed) BG (Completed) HR (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2007-001906-26 Sponsor Protocol Number: 2007-22-INJ-17 Start Date*: 2008-09-10
    Sponsor Name:HEXAL AG
    Full Title: Randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenicity of subcutaneous EPO HEXAL vs. ERYPO® in the treatment of anemia associated with chronic renal...
    Medical condition: anemia associated with chronic renal insufficiency in predialysis patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058116 Nephrogenic anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) SK (Completed) FR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2011-002871-40 Sponsor Protocol Number: HX575-308 Start Date*: 2012-02-28
    Sponsor Name:Hexal AG
    Full Title: Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialy...
    Medical condition: anemia associated with chronic kidney disease in pre-dialysis and dialysis patients
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004851 10058124 Nephrogenic anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002032-26 Sponsor Protocol Number: BH 18387 Start Date*: 2004-12-23
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: An open-label, multi-center study to document the efficacy, safety and tolerability of long-term administration of RO0503821 in patients with chronic renal anemia
    Medical condition: Patient with chronic renal anaemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FI (Completed) HU (Completed) DK (Completed) SE (Completed) CZ (Completed) NO (Completed) IT (Completed) DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-005129-31 Sponsor Protocol Number: BH21260 Start Date*: 2008-10-22
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not...
    Medical condition: To gain more experience with MIRCERA administered under clinical practice conditions and according to the approved label by performing a non-inferiority study comparing MIRCERA to other ESAs in ter...
    Disease: Version SOC Term Classification Code Term Level
    19.1 10005329 - Blood and lymphatic system disorders 10058116 Nephrogenic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) CZ (Completed) IT (Completed) SE (Completed) LT (Completed) GR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2004-000081-13 Sponsor Protocol Number: BA 17284 Start Date*: 2004-09-07
    Sponsor Name:F Hoffmann-La Roche Ltd
    Full Title: A randomized, controlled, open-label, multi-center, parallel group study to demonstrate efficacy and safety of RO0503821 when administered with pre-filled syringes for the maintenance treatment of ...
    Medical condition: Patients with Chronic Kidney Disease who are on dialysis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-010904-27 Sponsor Protocol Number: MK-2578-003 Start Date*: 2009-09-07
    Sponsor Name:MERCK & CO., INC.
    Full Title: A Phase II Randomized, Open-Label, Multiple-Rising Dose Clinical Trial to Study the Efficacy and Safety of MK-2578 for the Maintenance of Anemia Treatment in Patients With Chronic Kidney Disease...
    Medical condition: Anemia in patient with Kidney Disease (CKD)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10009120 Chronic renal failure anaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005728-34 Sponsor Protocol Number: 2006-66-INJ-14 Start Date*: 2008-02-27
    Sponsor Name:Hexal Biotech ForschungsGmbH
    Full Title: Post authorisation safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human ...
    Medical condition: Chronic kidney disease subjects with or without dialysis treatment and requiring i.v. ESA treatment
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009120 Chronic renal failure anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) IT (Completed) FR (Completed) GB (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-003190-34 Sponsor Protocol Number: ACE-536-MDS-002 Start Date*: 2019-01-02
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Ris...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) LT (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004779-39 Sponsor Protocol Number: NH19708 Start Date*: 2018-02-26
    Sponsor Name:Roche Farma S.A(Soc unipersonal)que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche LTD.
    Full Title: AN OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO ASCERTAIN THE OPTIMAL STARTING DOSE OF MIRCERA® GIVEN SUBCUTANEOUSLY FOR THE MAINTENANCE TREATMENT OF ANEMIA IN PEDIATRIC PATIENTS WITH CHRONIC KIDNE...
    Medical condition: Chronic renal anemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10058132 Renal anemia LLT
    20.0 100000004851 10072870 Chronic anemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) LT (Completed) HU (Completed) FR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007758-70 Sponsor Protocol Number: NH19707 Start Date*: 2008-06-24
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: An open-label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA® for maintenance treatment of anemia in pediatric patients with chronic kidney disease ...
    Medical condition: Anemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10058124 Nephrogenic anemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) FR (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-002696-27 Sponsor Protocol Number: HX575-304 Start Date*: 2008-12-04
    Sponsor Name:Hexal AG
    Full Title: An open label, single-arm, baseline-controlled, multicenter study to evaluate the efficacy, safety and immunogenicity of subcutaneous HX575 administered once a week (qw) and once every two weeks (q...
    Medical condition: Anemia associated with chronic kidney disease in pre-dialysis and dialysis subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009120 Chronic renal failure anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) SK (Prematurely Ended) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004032-75 Sponsor Protocol Number: ML20572 Start Date*: 2007-02-09
    Sponsor Name:Roche Pharma AG
    Full Title: An open-label, multi-center study to demonstrate the efficacy and safety of C.E.R.A when administered intravenously with pre-filled syringes (PFS) for the treatment of anemia in patients with chron...
    Medical condition: renal anemia due to chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058116 Nephrogenic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000780-40 Sponsor Protocol Number: D5740C00002 Start Date*: 2014-11-11
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
    Medical condition: Anemia in chronic kidney disease patients with dialysis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) SK (Completed) HU (Completed) ES (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-000983-29 Sponsor Protocol Number: MA 17502 Start Date*: 2005-01-12
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: Effectiveness of a once weekly subcutaneous epoetin beta treatment in hemodialysis patients.
    Medical condition: Renal anemia in hemodialysis patients
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058116
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004372-56 Sponsor Protocol Number: 204837 Start Date*: 2018-07-04
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A Phase 3 randomized, double-blind, active-controlled, parallel-group, multi-center study in hemodialysis participants with anemia of chronic kidney disease to evaluate the efficacy, safety and pha...
    Medical condition: anemia associated with chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) GB (Completed) PL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2006-004552-21 Sponsor Protocol Number: BH20051 Start Date*: 2007-02-21
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in pati...
    Medical condition: Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058124 Nephrogenic anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) GB (Completed) IT (Completed) BE (Completed) CZ (Completed) HU (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-005799-15 Sponsor Protocol Number: ML21438 Start Date*: 2008-04-08
    Sponsor Name:ROCHE
    Full Title: A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for the maintenance of haemoglobin levels in haemodialysis pati...
    Medical condition: Chronic renal anemia.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039812 Secondary anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001721-97 Sponsor Protocol Number: ML20826 Start Date*: 2007-10-15
    Sponsor Name:Roche Pharma (Schweiz) AG
    Full Title: An single arm, open label, interventional multicenter study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for the maintenance of haemoglobin...
    Medical condition: chronic renal anemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-000914-19 Sponsor Protocol Number: EPO-ANE-4008 Start Date*: 2006-10-23
    Sponsor Name:Janssen-Cilag International N.V., Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatme...
    Medical condition: Anemia in cancer patients receiving chemotherapy MedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Completed) SK (Completed) GR (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
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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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