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Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/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 Correction or Maintenance Treatment of Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2024

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At a glance

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

    • Most Recent Events

    • 28 Mar 2024 According to an Akebia Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months, based on efficacy and safety data from the INNO2VATE program and an assessment of post marketing safety data from Japan where Vafseo was launched in August 2020.
    • 27 Mar 2024 According to an Akebia Therapeutics media release, company will host a conference call on Thursday, March 28 at 8:00 a.m. Eastern Time to discuss the approval and planned next steps for launch.
    • 25 Oct 2023 According to an Akebia Therapeutics media release, the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis, was complete. The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.
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