Investigators confirmed the efficacy and long-term safety of roxadustat compared with darbepoetin in patients with anemia of chronic kidney disease (CKD) not receiving dialysis, according to a presentation at Kidney Week 2020 Reimagined, a virtual meeting sponsored by the American Society of Nephrology.
Tadao Akizawa, MD, PhD, of Showa University School of Medicine in Tokyo, Japan, and colleagues tested the efficacy of roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), after conversion from the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa, recombinant human erythropoietin (rHuEPO), and epoetin beta pegol. A total of Japanese 262 patients previously receiving darbepoetin or rHuEPO were randomly assigned to receive roxadustat or darbepoetin for 24 weeks. Separately, 70 patients taking epoetin also converted to roxadustat to form a reference group.
Roxadustat proved noninferior to darbepoetin in patients with nondialysis CKD, Dr Akizawa’s team reported. At 18-24 weeks, average hemoglobin (Hb) in the roxadustat group was within target range at 11.14 g/dL, with a between-group difference within the lower limit of the 95% confidence interval. Hb levels were also maintained through 52 weeks in roxadustat-treated patients converted from darbepoetin or rHuEPO (11.05 g/dL) and from epoetin (10.7 g/dL).
By 52 weeks, 76.3%, and 78.6% of roxadustat patients converted from darbepoetin or rHuEPO and, separately, epoetin had achieved target-range Hb levels, respectively. Mean iron, ferritin, total iron-binding capacity, transferrin saturation, and hepcidin remained stable throughout.
“Roxadustat represents an effective alternative to darbepoetin in patients with nondialysis dependent CKD anemia,” Dr Akizawa’s team concluded.
Treatment-emergent adverse events (AEs) occurred in 78.6% of the roxadustat group converted from darbepoetin, 70.2% of the darbepoetin group, and 77.1% of the roxadustat group converted from epoetin over 24 weeks. The most common treatment-emergent AEs, including nasopharyngitis, CKD, hyperkalemia, and hypertension, occurred in similar proportions of each group and were consistent with previous reports.
Disclosure: This clinical trial was supported by Astellas Pharma. Please see the original reference for a full list of authors’ disclosures.
Akizawa T, Iwasaki Manabu, Otsuka T, Yamaguchi Y, Reusch M. A phase 3, multicenter, randomized, open-label, active comparator conversion study of roxadustat in non-dialysis-dependent (NDD) patients with anemia in CKD. Presented at: Kidney Week 2020 Reimagined; October 19-25, 2020. Poster PO0269.