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A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

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Trial Profile

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2023

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At a glance

  • Drugs Daprodustat (Primary) ; Darbepoetin alfa; Darbepoetin alfa; Epoetin alfa; Recombinant erythropoietin
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASCEND-D
  • Sponsors GlaxoSmithKline; 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.
    • 24 Dec 2022 Results of post-hoc analysis of two studies (ASCEND-ND & ASCEND-D) assessing analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents, published in the Nephrology Dialysis Transplantation.
    • 06 Sep 2022 According to a GlaxoSmithKline media release, results from the trial were presented at the American Society of Nephrology Kidney Week 2021.

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