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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: 21 Oct 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

    • 15 Oct 2024 According to Akebia Therapeutics Media Release, Analyses of Cardiovascular Safety 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.
    • 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.

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