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Clinical trials for Darbepoetin 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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    73 result(s) found for: Darbepoetin alfa. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2006-003173-27 Sponsor Protocol Number: 20060163 Start Date*: 2009-04-14
    Sponsor Name:Amgen Limited
    Full Title: A Multi-Center, Single Arm Study Evaluating De Novo Once Monthly (QM) Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects with Chronic Kidney Disease (CKD) Not Receiving Dialysis
    Medical condition: Anemia in subjects with chronic kidney disease not receiving dialysis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) CZ (Completed) HU (Completed) AT (Prematurely Ended) BE (Completed) LV (Completed) IT (Completed) ES (Completed) PT (Completed) GB (Completed) DE (Completed) PL (Completed) DK (Completed) EE (Completed) SI (Completed) SK (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2005-005278-59 Sponsor Protocol Number: 20050222 Start Date*: 2006-12-22
    Sponsor Name:Amgen Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symp...
    Medical condition: Heart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10007559 Cardiac failure congestive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) LT (Completed) SK (Completed) BE (Completed) EE (Completed) FI (Completed) HU (Completed) DK (Completed) DE (Completed) CZ (Completed) ES (Completed) SE (Completed) AT (Completed) PT (Completed) NL (Completed) LV (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-000542-65 Sponsor Protocol Number: 200808 Start Date*: 2016-11-14
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to ...
    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: HU (Completed) BE (Completed) GB (GB - no longer in EU/EEA) DK (Completed) AT (Prematurely Ended) CZ (Completed) DE (Completed) PT (Completed) SE (Completed) ES (Completed) NL (Completed) BG (Completed) GR (Completed) FR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    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: 2004-000134-37 Sponsor Protocol Number: 20010184 Start Date*: 2004-09-14
    Sponsor Name:Amgen Inc.
    Full Title: Trial to Reduce Cardiovascular Events with Aranesp Therapy
    Medical condition: Treatment of anaemia in subjects with chronic kidney disease (CKD) amd Type 2 diabetes mellitus (DM)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10038444 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed) LV (Completed) SE (Completed) IT (Completed) DK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-004178-10 Sponsor Protocol Number: 20040104 Start Date*: 2005-01-11
    Sponsor Name:Amgen Limited
    Full Title: A Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for ...
    Medical condition: Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    6.1 10038444 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) CZ (Completed) GB (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    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: 2006-000074-79 Sponsor Protocol Number: 20050210 Start Date*: 2006-05-19
    Sponsor Name:Amgen Ltd
    Full Title: A Multicenter, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
    Medical condition: Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
    Disease: Version SOC Term Classification Code Term Level
    7.0 10049105 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001190-24 Sponsor Protocol Number: BAY85-3934/15653 Start Date*: 2013-11-12
    Sponsor Name:Bayer AG
    Full Title: A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY 85-3934 and darbepoetin alfa comparator in the long term treatment of anemia in ...
    Medical condition: Anaemia of Chronic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10058123 Renal anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) IT (Completed) HU (Completed) ES (Completed) BG (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-004510-33 Sponsor Protocol Number: BH17847 Start Date*: 2006-11-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A randomized, controlled, open-label, multi-center, parallel-group study to compare the efficacy and safety of RO0503821 with that of darbepoetin alfa administered intravenously at extended dosing ...
    Medical condition: Chronic renal anemia
    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) GB (Completed) AT (Completed) FI (Completed) BE (Completed) PT (Completed) NL (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-005405-37 Sponsor Protocol Number: NH19960 Start Date*: 2006-06-28
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A multicenter, randomized, open-label dose finding study of RO0503821 in anemic patients with stage IIIB or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy
    Medical condition: Anemic patients undergoing chemotherapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended) FI (Prematurely Ended) BE (Completed) ES (Completed) CZ (Completed) EE (Prematurely Ended) HU (Prematurely Ended) IT (Prematurely Ended) GR (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: 2004-001417-33 Sponsor Protocol Number: 20040156 Start Date*: 2004-10-19
    Sponsor Name:Amgen Inc
    Full Title: A Randomized Open-Label Study of Darbepoetin alfa Administered Every Three Weeks with or without Parenteral Iron in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy
    Medical condition: Chemotherapy induced anemia
    Disease: Version SOC Term Classification Code Term Level
    7.0 10049105 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SE (Completed) FI (Completed) AT (Completed) CZ (Completed) GB (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2007-005792-34 Sponsor Protocol Number: 20070782 Start Date*: 2009-07-09
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks (Q3W) in Anemic Subjects With Advanc...
    Medical condition: Anemia in subjects with advanced stage non-small cell lung cancer receiving multi-cycle chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004851 10064469 Anemia post chemotherapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IE (Prematurely Ended) CZ (Prematurely Ended) AT (Prematurely Ended) BE (Completed) ES (Prematurely Ended) DE (Completed) NL (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended) SI (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-001721-34 Sponsor Protocol Number: 20050197 Start Date*: Information not available in EudraCT
    Sponsor Name:Amgen Inc
    Full Title: A Phase 2, Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Darbepoetin alfa for the Treatment of Anemia in Paediatric Subjects with Solid Tumours Receiving Cyclic Chemotherapy
    Medical condition: Chemotherapy-induced anemia (CIA)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064469 Anemia post chemotherapy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (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: 2008-003418-88 Sponsor Protocol Number: 20050256 Start Date*: 2009-02-04
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Double-blind, Randomized Study Evaluating De Novo Weekly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease ...
    Medical condition: Treatment of anemia with darbepoetin alfa in pediatric subjects with chronic kidney disease (CKD) receiving and not receiving dialysis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064848 Chronic kidney disease LLT
    9.1 10002272 Anemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) LV (Completed) BE (Completed) LT (Prematurely Ended) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001192-21 Sponsor Protocol Number: BAY85-3934/15261 Start Date*: 2013-12-12
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, parallel group, open-label, multicenter study to investigate the efficacy and safety of oral BAY 85-3934 and active comparator (darbepoetin alfa) in the maintenance treatment of anemi...
    Medical condition: Anaemia of Chronic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004851 10058132 Renal anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) IT (Completed) ES (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004774-14 Sponsor Protocol Number: AKB-6548-CI-0015 Start Date*: 2016-06-03
    Sponsor Name:Akebia Therapeutics, Inc.
    Full Title: Phase 3, randomized, open-label, active-controlled study evaluating the efficacy and safety of oral vadadustat for the maintenance treatment of anemia in subjects with non-dialysis-dependent chroni...
    Medical condition: Anemia in chronic kidney disease patients not on dialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    20.0 100000004857 10076410 Chronic kidney disease stage 3 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) AT (Completed) CZ (Completed) ES (Completed) BG (Completed) SK (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000951-42 Sponsor Protocol Number: 1517-CL-0610 Start Date*: 2013-12-04
    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 Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
    Medical condition: Anemia in Chronic Kidney Disease patients not on Dialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) NL (Completed) CZ (Completed) SK (Completed) SI (Completed) PT (Completed) AT (Completed) IE (Completed) DK (Completed) FI (Completed) LV (Completed) SE (Completed) FR (Completed) HR (Completed) HU (Completed) BG (Completed)
    Trial results: View results
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