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A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo

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A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2023

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At a glance

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

    • Most Recent Events

    • 01 Jun 2023 Results published in the Kidney International
    • 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, 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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