Phase 3 trial results of daprodustat show noninferiority to ESAs
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The oral anemia drug daprodustat showed noninferiority to erythropoiesis-stimulating agents for achieving targeted hemoglobin levels and cardiovascular risk in patients with kidney disease on dialysis and not on dialysis, according to phase 3 data presented at ASN Kidney Week.
Ajay K. Singh, MB, BS, MBA, a nephrologist at Brigham and Women's Hospital in Boston and lead investigator of the ASCEND (Anemia Studies in Chronic Kidney Disease) ND (no dialysis) and D (dialysis) pivotal trials, presented the results during the virtual meeting. The findings were simultaneously published in the New England Journal of Medicine.
Daprodustat (GlaxoSmithKline) is a hypoxia-inducible factor prolyl hydroxylase inhibitor. Among the 8,000 patients enrolled in five ASCEND trials, daprodustat improved or maintained hemoglobin within target levels, without increased cardiovascular risk when compared to standard of care, according to a GlaxoSmithKline press release.
Safety endpoints were also met in the trials. Results from the prespecified primary safety analysis of the intention-to-treat population showed similar rates of major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction or non-fatal stroke independently within each trial, according to the release.
“For both the hemoglobin co-primary and the MACE co-primary, in both ASCEND-D and the ASCEND–ND trials, we met the criteria for noninferiority,” Singh told Healio Nephrology.
Of the patients in the study, Singh said 89% were prevalent patients on in-center hemodialysis, and 11% were patients on peritoneal dialysis, “which is roughly what you would see in the U.S. dialysis population,” he said.
About 50% of patients had diabetes, and 45% to 50% had cardiovascular disease, he said.
“Most of the patients – around 65% to 70% – in the [non-dialysis] patient population centered around stages 3-4,” Singh said.
ASCEND-TD, which is one of the five trials, looked at the efficacy of daprodustat when administered daily vs. three times a week administration in dialysis patients only.
“The ASCEND-TD trial showed positive efficacy results for three-times weekly dosing, in addition to the once-daily dosing regimen evaluated in ASCEND-ND and ASCEND-D studies,” Singh said.
Daprodustat is currently approved in Japan as Duvroq for patients with renal anemia.
References:
- Singh A, et al. NEJM,2021;doi:10.1056/NEJMoa2113379.
- Singh A, et al. NEJM,2021;doi:10.1056/NEJMoa2113380.
- www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-phase-iii-efficacy-and-safety-data-for-daprodustat-in-patients-with-anaemia-due-to-chronic-kidney-disease/
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Singh AK, et al. Paper FR-OR66. Presented at: ASN Kidney Week; Nov. 4-7, 2021 (virtual meeting).
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