Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: A phase 3, randomized, double-blind, placebo-controlled study (ALPS)
Nephrology Dialysis Transplantation Mar 03, 2021
Shutov E, Sułowicz W, Esposito C, et al. - In patients suffering from stage 3-5 chronic kidney disease not on dialysis, researchers determined the efficacy of roxadustat vs placebo for anemia treatment. For this phase 3, multicenter, randomized, double-blind, placebo-controlled study, participants were randomly assigned (2:1) to oral roxadustat or placebo three times weekly for 52-104 weeks. This study included 594 patients (roxadustat: 391; placebo: 203). Findings revealed that, both in terms of hemoglobin (Hb) response rate and alteration in Hb from baseline, roxadustat was more efficacious than placebo. For both LDL cholesterol change from baseline and time to first use of rescue medication, roxadustat had greater efficacy than placebo. Roxadustat and placebo displayed comparable safety profiles.
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