GlaxoSmithKline starts Phase 3 program investigating daprodustat
GlaxoSmithKline announced the start of a phase III development program investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a treatment for anaemia associated with chronic kidney disease. The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to recombinant human erythropoietin: ASCEND-D will enrol approximately 3,000 dialysis dependent subjects with anaemia associated with CKD switching from an erythropoietin-stimulating agent. ASCEND-ND will enrol approximately 4,500 non-dialysis dependent subjects with anaemia associated with CKD, and will include patients either switching from or naive to an ESA. For both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52). The studies will assess whether daprodustat is non-inferior to recombinant human erythropoietin on these endpoints as the primary analysis. If non-inferiority of the primary analysis is met, superiority will be assessed for the safety endpoint. The design of the phase III program is based upon data from phase II clinical trials that were designed to characterise the dose-response relationship between daprodustat and haemoglobin at 4 weeks and assess the safety and tolerability of daprodustat following once-daily administration up to 24 weeks. Data from the 24-week phase II studies were presented at the American Society of Nephrology Kidney Week congress in Chicago, Illinois, earlier in November.