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Clinical trials for Akebia

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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    6 result(s) found for: Akebia. Displaying page 1 of 1.
    EudraCT Number: 2015-004265-81 Sponsor Protocol Number: AKB-6548-CI-0014 Start Date*: 2016-06-23
    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 correction of anemia in subjects with non-dialysis-dependent chronic kidney di...
    Medical condition: Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) patients
    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) ES (Completed) BG (Completed) GB (Completed) IT (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: 2016-001360-11 Sponsor Protocol Number: AKB-6548-CI-0017 Start Date*: 2017-04-25
    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 Dialysis-Dependent Chronic Ki...
    Medical condition: Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) PT (Completed) BG (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004022-30 Sponsor Protocol Number: AKB-6548-CI-0041 Start Date*: 2022-03-02
    Sponsor Name:Akebia Therapeutics, Inc.
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE AFTER CONVERSION FROM...
    Medical condition: Anemia of Chronic kidney disease (CKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) ES (Ongoing) FR (Prematurely Ended) PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003994-72 Sponsor Protocol Number: AKB-6548-CI-0042 Start Date*: 2022-03-02
    Sponsor Name:Akebia Therapeutics, Inc.
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAÏVE TO ERYTHROPOIES...
    Medical condition: Anemia of Chronic kidney disease (CKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000838-21 Sponsor Protocol Number: AKB-6548-CI-0016 Start Date*: 2017-04-25
    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 Correction or Maintenance Treatment of Anemia in Subjects with Incident Dialys...
    Medical condition: Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) IT (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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