Daprodustat

Unassigned

New Medicines

Anaemia in chronic kidney disease in patients not on dialysis and on dialysis

Information

New molecular entity
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A small molecule prolyl hydroxylase inhibitor
UK prevalence of stage 3-5 CKD is about 8.5% (8,500 per 100,000 people). Prevalence of anaemia in CKD (defined as a haemoglobin level less than 12 g/dL in men and postmenopausal women and less than 11 g/dL in premenopausal women) is about 12% [1].
Anaemia in chronic kidney disease in patients not on dialysis and on dialysis
Oral

Trial or other data

Nov 16: GSK begins a PIII programme including two studies evaluating daprodustat safety and efficacy compared to recombinant human erythropoietin in dialysis dependent subjects with anaemia associated with CKD (ASCEND-D) and in non-dialysis dependent patients with the condition (ASCEND-ND). The co-primary endpoints for both trials are time to first occurrence of major adverse cardiovascular events (MACE) and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52) [2].