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 Kidney Disease (DD-CKD) (INNO2VATE-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 Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2018

At a glance

  • Drugs Vadadustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms INNO2VATE-CONVERSION
  • Sponsors Akebia Therapeutics
  • Most Recent Events

    • 19 Mar 2018 Planned number of patients changed from 2200 to 2800.
    • 12 Feb 2018 According to an Akebia Therapeutics media release, enrolment completion expected by the end of 2018 and top-line results expected in 2019, subject to the accrual of MACE events.
    • 09 May 2017 According to an Akebia Therapeutics media release, the Independent Data Monitoring Committee recommended continuing the studies without modification.
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