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)

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2018

At a glance

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

    • 31 Jul 2018 Planned End Date changed from 1 Sep 2019 to 1 Aug 2020.
    • 31 Jul 2018 Planned primary completion date changed from 1 Sep 2019 to 1 Aug 2020.
    • 09 May 2018 According to an Akebia Therapeutics media release, the Independent Data Monitoring Committee of PRO2TECT program held another meeting and recommended continuing the study without modification.
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