Molidustat maintains mean hemoglobin (Hb) levels within a target range of 10.0 to less than 12.0 g/dL in patients undergoing hemodialysis and has proven noninferior to darbepoetin, according to a poster presentation at the American Society of Nephrology’s Kidney Week 2020 Reimagined.
In the double-blind, phase 3 MIYABI HD-M trial (Molidustat Once Daily Improves Renal Anemia by Inducing EPO – Hemodialysis Maintenance; NCT03543657), investigators randomly assigned 229 Japanese patients to oral molidustat (5-200 mg/d), an investigational hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), or darbepoetin alfa (10-180 μg every 1 or 2 weeks), an injectable erythropoiesis-stimulating agent (ESA), for 52 weeks. Mean baseline Hb levels were 10.77 g/dL for molidustat and 10.84 g/dL for darbepoetin alfa.
Over a median 364 days, mean Hb was maintained at 10.63 g/dL with molidustat compared with 10.77 g/dL with darbepoetin alfa, Tadao Akizawa, MD, of Showa University in Tokyo, Japan, and colleagues reported. For molidustat, 49.6% to 77.8% of patients had their mean Hb within target range from weeks 2 to 52. Furthermore, molidustat proved noninferior to darbepoetin alfa based on a noninferiority margin of 1.0 g/dL, according to the team. Molidustat also recently demonstrated noninferiority to darbepoetin in patients not receiving dialysis.
There were no major differences between groups in treatment-emergent adverse events (TEAEs; molidustat, 95.4% vs darbepoetin alfa, 94.7%), serious TEAEs (24.2% vs 18.4%), TEAEs with an outcome of death (1.3% vs 1.3%), or major adverse cardiovascular events (3.3% vs 2.6%). With respect to AEs of special interest, ocular events occurred in 30.1% vs 18.4% of the molidustat and darbepoetin group, respectively, and neoplasms in 9.8% vs 5.3%, respectively.
Disclosure: This clinical trial was supported by Bayer Yakuhin Ltd. Please see the original reference for a full list of authors’ disclosures.
Akizawa T, Yamada T, Nobori K, et al. Results from a phase 3 study comparing the efficacy and safety of molidustat vs darbepoetin alfa in patients receiving hemodialysis and treated with erythropoiesis-stimulating agents (ESAs). Presented at: Kidney Week 2020 Reimagined, October 19-25, 2020. Poster PO2623.