Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis

This phase 3 trial evaluated the efficacy and safety of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, compared with darbepoetin alfa in 3872 patients with chronic kidney disease (CKD) and anemia not undergoing dialysis. The primary outcomes were the mean change in hemoglobin levels from baseline to weeks 28–52 and the first occurrence of a major adverse cardiovascular event (MACE). Daprodustat was noninferior to darbepoetin alfa in hemoglobin response (mean difference: 0.08 g/dL; 95% CI, 0.03–0.13) and cardiovascular safety (MACE hazard ratio: 1.03; 95% CI, 0.89–1.19). Adverse events were similar between groups, though daprodustat was associated with higher rates of cancer-related events and gastrointestinal erosions

This phase 3 trial evaluated the efficacy and safety of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, compared with darbepoetin alfa in 3872 patients with chronic kidney disease (CKD) and anemia not undergoing dialysis. The primary outcomes were the mean change in hemoglobin levels from baseline to weeks 28–52 and the first occurrence of a major adverse cardiovascular event (MACE). Daprodustat was noninferior to darbepoetin alfa in hemoglobin response (mean difference: 0.08 g/dL; 95% CI, 0.03–0.13) and cardiovascular safety (MACE hazard ratio: 1.03; 95% CI, 0.89–1.19). Adverse events were similar between groups, though daprodustat was associated with higher rates of cancer-related events and gastrointestinal erosions