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Clinical trials for Roxadustat

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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    8 result(s) found for: Roxadustat. Displaying page 1 of 1.
    EudraCT Number: 2017-001773-17 Sponsor Protocol Number: FGCL-4592-082 Start Date*: 2017-11-06
    Sponsor Name:FibroGen, Inc.
    Full Title: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome...
    Medical condition: Anemia due to Myelodysplastic Syndrome (MDS) in International Prognostic Scoring System – Revised Very Low, Low, or Intermediate Risk with <5% Blasts, and has low red blood cell transfusion burden ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Ongoing) GB (GB - no longer in EU/EEA) BE (Completed) DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002924-18 Sponsor Protocol Number: 1517-CL-1001 Start Date*: 2019-07-11
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye free Mini-tablet (Solid and Suspension)...
    Medical condition: Healthy Adult Volunteers (intended indication is anemia associated with chronic kidney disease (CKD))
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (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
    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: 2014-000770-19 Sponsor Protocol Number: D5740C00001 Start Date*: 2015-01-16
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients not on D...
    Medical condition: Anemia in chronic kidney disease patients without dialysis.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    20.0 100000004857 10076410 Chronic kidney disease stage 3 LLT
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed) HU (Completed) DE (Completed) ES (Completed) BG (Completed) PL (Completed) RO (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: 2012-005180-27 Sponsor Protocol Number: 1517-CL-0608 Start Date*: 2013-06-24
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis
    Medical condition: Anemia in CKD 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) BE (Completed) HU (Completed) IT (Completed) ES (Completed) BG (Completed) PL (Completed) EE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002753-30 Sponsor Protocol Number: FGCL-4592-063/CFG13001 Start Date*: 2014-01-15
    Sponsor Name:FibroGen, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-dialysis Patients.
    Medical condition: Anemia due to end-stage renal disease in incident-dialysis patients.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10054606 Secondary anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) BG (Completed) LV (Completed) PL (Completed)
    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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