Phase III ASCEND studies of Duvroq meet their primary endpoints in anaemia due to chronic kidney disease.- GlaxoSmithKline
The positive primary efficacy and safety results confirm the potential for daprodustat to be a new oral treatment for patients with anaemia due to chronic kidney disease (CKD) in both non-dialysis and dialysis settings. The ASCEND-ND and ASCEND-D studies each independently met their primary efficacy and safety endpoints.
Efficacy results from both Phase III studies demonstrated that daprodustat improved or maintained patients within their target haemoglobin (Hb) range. In addition, results from the prespecified primary safety analysis of the intention-to-treat (ITT) 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. In the ASCEND-ND trial, results showed a hazard ratio reflecting time to first occurrence of MACE of 1.03; 95% CI, (0.89 to 1.19), achieving non-inferiority with the pre-defined margin of 1.25. In the ASCEND-D trial, results showed a hazard ratio reflecting time to first occurrence of MACE of 0.93; 95% CI, (0.81-1.07), achieving non-inferiority with the pre-defined margin of 1.25.
The outcomes in each study and across treatment arms confirmed no increased cardiovascular risk for daprodustat compared to an erythropoietin stimulating agent (ESA), the current standard of care. The most commonly reported adverse events in patients receiving daprodustat included hypertension, diarrhoea, dialysis hypotension, peripheral oedema and urinary tract infection. Data on daprodustat, including results from the two pivotal Phase III studies focused on non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients, were shared at the American Society of Nephrology’s meeting in a combined late-breaking oral presentation. Results for ASCEND-ND and ASCEND-D were also published simultaneously in the New England Journal of Medicine. Data were announced during a presentation at the American Society of Nephrology’s Kidney Week 2021.
See- "Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis". Ajay K. Singh, M.B., B.S., M.B.A., Kevin Carroll, Ph.D., John J.V. McMurray, M.D., Scott Solomon, M.D., Vivekanand Jha, M.D., et al., for the ASCEND-ND Study Group.November 5, 2021. DOI: 10.1056/NEJMoa2113380.NEJM.
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