Singh AK, Carroll K, McMurray JJV, et al. - Findings demonstrate noninferiority of daprodustat (an oral hypoxia-inducible factor prolyl hydroxylase inhibitor) to darbepoetin alfa regarding change in the hemoglobin level from baseline as well as regarding cardiovascular outcomes in patients with chronic kidney disease (CKD) and anemia who were not on dialysis.

• In this randomized, open-label, phase 3 trial with blinded adjudication of cardiovascular outcomes, a total of 3,872 patients with CKD and anemia who were not undergoing dialysis were randomized to receive daprodustat or darbepoetin alfa.

• From baseline to weeks 28 through 52, the mean (±SE) change in the hemoglobin level was 0.74±0.02 g per deciliter and 0.66±0.02 g per deciliter in the daprodustat and darbepoetin alfa groups, respectively (difference, 0.08 g per deciliter), which met the prespecified noninferiority margin of −0.75 g per deciliter.

• In 19.5% patients in the daprodustat group and 19.2% in the darbepoetin alfa group, occurrence of a first major adverse cardiovascular event was noted during a median follow-up of 1.9 years (hazard ratio, 1.03), which met the prespecified noninferiority margin of 1.25.

• In the two groups, the percentage of patients with adverse events were similar.