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Roxadustat for anemia in patients with kidney disease not receiving dialysis

New England Journal of Medicine Jul 30, 2019

Chen N, et al. - Considering the phase 2 studies involving patients with chronic kidney disease in which levels of endogenous erythropoietin increased to within or near the physiologic range using roxadustat, along with an increase in hemoglobin levels and improvement in iron homeostasis, researchers conducted this phase 3 trial at 29 sites in China to generate additional data regarding the effectiveness and safety of roxadustat for treating anemia in patients with chronic kidney disease who are not undergoing dialysis. One hundred fifty-four patients with chronic kidney disease were randomly assigned in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks in a double-blind manner. Patients in the roxadustat group showed a greater mean hemoglobin level than those in the placebo group after 8 weeks. Roxadustat was correlated with continued efficacy during the 18-week open-label phase of the trial. The roxadustat group vs the placebo group experienced hyperkalemia and metabolic acidosis more frequently.
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