Akizawa T, Tanaka-Amino K, Otsuka T, et al. - Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is used for managing anemia of chronic kidney disease (CKD). In this post hoc analysis of a Japanese, open-label, partially randomized, phase 3 study in nondialysis-dependent (NDD) CKD patients treated with traditional erythropoiesis-stimulating agents (ESAs), researchers examined dosing trends of roxadustat and darbepoetin alfa (DA) necessitated to maintain target hemoglobin concentrations in cases with risk factors linked with ESA hyporesponsiveness.

• Patients were included from the 1517-CL-0310 study (NCT02988973), in which, roxadustat was demonstrated as noninferior to DA for change in average hemoglobin levels of week 18–24 from baseline who had used human recombinant erythropoietin or DA before conversion and who were randomized to either roxadustat or DA.

• Randomization of 262 patients to either the roxadustat or DA comparative group was done (roxadustat, n = 131; DA, n = 131).

• Patients in the highest ESA resistance index (≥ 6.8) quartile required higher mean (standard deviation) doses of both roxadustat (63.15 [24.84] mg) and DA (47.33 [29.79] μg).

• The lowest doses for both roxadustat (45.54 [18.01] mg) and DA (28.13 [20.98] μg) were required in patients with adequate iron repletion.

• Higher DA but not roxadustat doses were required in cases with high-sensitivity C-reactive protein ≥ 28.57 nmol/L and the estimated glomerular filtration rate < 15 mL/min/1.73 m².

• Overall, in NDD patients in Japan with anemia of CKD, low-grade inflammation may not influence the roxadustat dose required to maintain target hemoglobin when compared with DA dose.

• Benefits may be achieved with providing roxadustat for ESA-hyporesponsive NDD CKD patients.