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A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis

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Trial Profile

A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Daprodustat (Primary) ; Darbepoetin alfa; Darbepoetin alfa; Iron
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND-ID
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 01 Feb 2023 According to a GlaxoSmithKline media release, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis.
    • 06 Sep 2022 According to a GlaxoSmithKline media release, results from the trial were presented at the American Society of Nephrology Kidney Week 2021.
    • 06 Sep 2022 According to a GlaxoSmithKline media release, the US Food and Drug Administration (FDA) will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application (NDA) for daprodustat, which is under regulatory review for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.

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