Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents (FO2RWARD)

Trial Profile

Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents (FO2RWARD)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Feb 2018

At a glance

  • Drugs Vadadustat (Primary) ; Epoetin alfa
  • Indications Anaemia
  • Focus Therapeutic Use
  • Acronyms FO2RWARD
  • Sponsors Akebia Therapeutics
  • Most Recent Events

    • 12 Feb 2018 According to an Akebia Therapeutics media release, the company is planning to replace the former FO2RWARD study and implement new study design which includes a broader dialysis population in addition to hyporesponders, a larger sample size and includes once-daily and three-times-weekly dosing. This new study anticipated to initiate in Q2 2018, with top-line results expected in late 2018 or early 2019. New study is designed to generate data to inform ESA-switching protocols.
    • 11 Jan 2018 Status changed from recruiting to active, no longer recruiting.
    • 14 Sep 2017 Planned number of patients changed from 78 to 50.
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