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A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

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A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2023

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At a glance

  • Drugs Vadadustat (Primary) ; Methoxy polyethylene glycol-epoetin beta
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FO2CUS
  • Sponsors Akebia Therapeutics

    • Most Recent Events

    • 14 Dec 2023 Status changed from active, no longer recruiting to completed.
    • 18 Oct 2023 According to an Akebia Therapeutics Media Release, data from this study will be presented at the American Society of Nephrology Kidney Week 2023 (ASN Kidney Week).
    • 03 Apr 2023 Primary endpoint (Mean change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive)) has been met, according to a Akebia Therapeutics media release.

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