Molidustat, an investigational anemia drug, is as effective as darbepoetin and epoetin in maintaining hemoglobin levels within target ranges for up to 36 months in patients with nondialysis chronic kidney disease (ND-CKD) and those on hemodialysis (HD), according to new study findings published in the American Journal of Nephrology.

In addition, molidustat was well tolerated, with an incidence of adverse events (AEs) similar to that of darbepoetin and epoetin.

Tadao Akizawa, MD, PhD, of Showa University in Japan, and colleagues recently evaluated molidustat, a novel hypoxia-inducible factor prolyl hydroxylase inhibitor, in 3 phase 2b studies from DIALOGUE (DaIly orAL treatment increasing endOGenoUs EPO) each lasting 16 weeks. Now Dr Akizawa and fellow investigators reveal results from 2 long-term DIALOGUE extension studies lasting up to 36 months. One study compared molidustat with darbepoetin in patients with ND-CKD and the other compared molidustat with epoetin in patients on HD.

In the ND-CKD study, 118 received individually dosed molidustat and 42 received darbepoetin. Mean hemoglobin (Hb) values in the molidustat and darbepoetin groups were 11.28 and 11.08 g/dL, respectively.  Mean Hb concentrations throughout the study were 11.10 and 10.98 g/dL in the modidustat and darbepoetin groups, respectively. Approximately 86% of both groups reported 1 or more adverse events.

In a second study of 88 HD patients treated long-term with molidustat, mean Hb levels at baseline for molidustat and epoetin recipients were 10.40 g/dL and 10.52 g/dL, respectively. During the study, mean Hb levels were 10.37 g/dL and 10.52 g/dL, respectively.

AEs occurred in 91.2% of molidustat and 93.3% of epoetin patients. Investigators observed no new safety signals.

“The present long-term extension studies showed promising efficacy and safety profiles for molidustat treatment and warrant further clinical trials,” Dr Akizawa and the team stated.

The DIALOGUE studies were funded by Bayer AG, the makers of molidustat.

Reference

Akizawa T, Macdougall IC, Berns JS, et al. Long-term efficacy and safety of molidustat for anemia in chronic kidney disease: DIALOGUE extension studies. Am J Nephrol 2019;49:271–280. DOI:10.1159/000499111