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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 Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

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Trial Profile

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 Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

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; Darbepoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PRO2TECT; PRO2TECT-CONVERSION
  • 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
  • 15 Oct 2024 According to Akebia Therapeutics Media Release, data from this study will be presented at the American Society of Nephrology Kidney Week 2024 (ASN Kidney Week), which will take place in San Diego, CA from October 24-27.
  • 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.

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