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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: 10 Jun 2025

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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

  • 04 Jun 2025 According to an Akebia Therapeutics media release, the data from this study has been published in Journal of the American Society of Nephrology
  • 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.

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