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This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

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Trial Profile

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2024

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At a glance

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

    • Most Recent Events

    • 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.
    • 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.
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