Effectiveness and long-term safety of repeated oral administrations of molidustat in the management of anemia associated with chronic kidney disease in cats

BACKGROUND: Erythropoietic effects of molidustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, occur in anemic cats with chronic kidney disease (CKD). HYPOTHESIS/OBJECTIVES: To evaluate the effectiveness and safety of molidustat in managing anemia in cats with CKD. ANIMALS: Seventy-five client-owned anemic cats with CKD in the effectiveness and safety phase and 64 in the safety continuation phase. METHODS: Multicenter, randomized, double-masked, placebo-controlled field study. Cats in the 28-day effectiveness and safety phase received 5 mg/kg of molidustat (n = 40) or a control product (CP; n = 35), once daily for 28 days. During the 20-week safety continuation phase, all cats received 5 mg/kg molidustat in 28-day treatment cycles once PCV declined to < 28%. Individual cat treatment success, defined as a ≥ 4% point increase in hematocrit (HCT) compared to baseline, was evaluated on day 28. Safety was assessed throughout both phases. RESULTS: Proportion of molidustat-treated cats with treatment success on day 28 (68% ± 7.4%; 95% CI, 51.45-80.28) was significantly higher compared to CP cats (17% ± 6.4%; 95% CI, 7.80-33.59; P < .001). During the safety continuation phase, median treatment cycle duration was 28 days with treatment intermission medians ranging from 11 to 18 days. There was no evidence of adverse effects attributed to molidustat when administered alone or in combination with other medications. CONCLUSIONS AND CLINICAL IMPORTANCE: Molidustat significantly increased HCT values in treated cats compared to CP cats. Repeated 28-day treatment cycles were well-tolerated. Molidustat is an effective and safe treatment for long-term management of anemia in cats with CKD.