A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs
Latest Information Update: 06 Feb 2023
At a glance
- Drugs Daprodustat (Primary) ; Epoetin alfa
- Indications Anaemia
- Focus Registrational; Therapeutic Use
- Acronyms ASCEND-TD
- Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK
- 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.