NEW YORK (Reuters Health) - Oral daprodustat works as well as injected darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease (CKD) starting dialysis, according to results of the ASCEND-ID trial.
The results, online in JAMA Internal Medicine, build on results from the ASCEND-ND and ASCEND-D trials published last year involving patients with anemia due to CKD in both the non-dialysis and dialysis settings.
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor being developed by GlaxoSmithKline, which funded the study.
The ASCEND-ID trial enrolled 312 adults (median age, 55 years) with advanced CKD who were planning to start dialysis within six weeks or who recently started receiving hemodialysis or peritoneal dialysis; 157 were randomly assigned to oral daily daprodustat and 155 to subcutaneous/intravenous darbepoetin alfa.
Daprodustat was noninferior to darbepoetin alfa in this patient population, report Dr. Ajay Singh of Brigham and Women's Hospital, in Boston, and colleagues.
The mean baseline hemoglobin concentration was 9.46 g/dL in the daprodustat group and 9.49 g/dL in the darbepoetin alfa group.
The difference in mean hemoglobin concentration between study arms during the 28- to 52-week evaluation period was 10.5 g/dL in the daprodustat group and 10.6 g/dL in the darbepoetin alfa group.
The efficacy of daprodustat was observed across key subgroups, including both hemodialysis and peritoneal dialysis patients and in those with planned versus unplanned dialysis starts.
Iron use, a key secondary outcome, was similar between groups and there was no significant reduction in iron use with daprodustat versus darbepoetin alfa.
"Overall, daprodustat's safety profile appeared to be similar to that of darbepoetin alfa, and no unexpected safety concerns were identified," the study team reports.
Daprodustat is currently approved in Japan. Last month, the company announced that the European Medicines Agency had validated the marketing application for the drug.
The drug is not yet approved in the U.S.
SOURCE: https://bit.ly/3tXFFjY JAMA Internal Medicine, online April 4, 2022.
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