Yamamoto H, Nobori K, Matsuda Y, et al. - Among Japanese patients who were not on dialysis and were not taking erythropoiesis-stimulating agent treatment, molidustat (an oral hypoxia-inducible factor prolyl hydroxylase inhibitor) seemed to have efficacy and general good tolerability as an alternative to darbepoetin for renal anemia treatment in the MIYABI (Molidustat Once Daily Improves Renal Anemia by Inducing EPO) Non-Dialysis Correction (ND-C) study.

• This 52-week, randomized (1:1), open-label, multicenter, phase 3 study included Japanese patients with renal anemia related to chronic kidney disease (stages 3–5).

• A total of 162 patients were randomly assigned to receive molidustat (n = 82) or darbepoetin (n = 80).

• Mean (95% confidence interval [CI]) for mean Hb concentrations during the evaluation span (weeks 30–36) for molidustat (11.28 [11.07, 11.50] g/dL) and darbepoetin (11.70 [11.50, 11.90] g/dL) was within the target range.

• In terms of change in mean hemoglobin level during the evaluation period from baseline, molidustat was noninferior to darbepoetin based on a noninferiority margin of 1.0 g/dL.

• For molidustat and darbepoetin, at least 1 treatment-emergent adverse event (TEAE) occurred in 93.9% and 93.7% patients, respectively.

• Mild or moderate intensity TEAEs occurred mostly, and 3 deaths occurred in the molidustat group and 1 in the darbepoetin group.