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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 Disease (NDD-CKD) (PRO2TECT-CORRECTION)

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Trial Profile

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 Disease (NDD-CKD) (PRO2TECT-CORRECTION)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Vadadustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PRO2TECT; PRO2TECT-CORRECTION
  • Sponsors Akebia Therapeutics

    • Most Recent Events

    • 23 Apr 2024 According to an Akebia Therapeutics media release, company announces the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Ferric Citrate Coordination Complex (AVA1014). The EMA will review the accepted application under the centralised marketing authorisation procedure and a decision on a potential approval is expected in 2025. The MAA submission is supported by three pivotal clinical studies performed by Akebia.
    • 18 Oct 2023 According to an Akebia Therapeutics media release, the company expects a Prescription Drug User Fee Act (PDUFA) date to be assigned before the end of October 2023.
    • 24 Aug 2023 According to an Akebia Therapeutics media release, the company expects to resubmit New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023. Upon acceptance of the NDA, Akebia expects the U.S. Food and Drug Administration (FDA) to set a PDUFA date of six months from the date of submission.
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