Roxadustat is well tolerated and effective for treating anemia in patients on peritoneal dialysis (PD) regardless of whether patients have received prior treatment with erythropoiesis stimulating agents (ESAs), a recent study found.
Outcomes included the maintenance rate of average hemoglobin (Hb) level within 10 to 12 g/dL at weeks 18 to 24; average Hb level at weeks 18 to 24; and cumulative response rate at the end of treatment (Hb thresholds 10.0 g/dL or 10.5 g/dL, or an Hb increase of 1.0 g/dL or higher).
In a 24-week phase 3, open-label trial, Tadao Akizawa, MD, PhD, of Showa University School of Medicine in Tokyo, and colleagues enrolled 56 anemic patients on PD. The group included 13 patients not previously treated with ESAs (ESA-naïve group) and 43 who received prior ESA treatment (ESA-converted group). The investigators randomly assigned patients in the ESA-naïve group to receive roxadustat at a starting dose of 50 mg or 70 mg 3 times per week. Patients in the ESA-converted group received 70 mg or 100 mg 3 times per week depending on the prior ESA dose.
Maintenance rates at weeks 18 to 24 were 92.3% and 74.4% in the ESA-naïve and ESA-converted groups, respectively, Dr Akizawa’s team reported in Therapeutic Apheresis and Dialysis. Average Hb levels during weeks 18 to 24 were 11.05 and 10.93 g/dL in the ESA-naïve and ESA-converted groups, respectively. The cumulative response rate was 100% in the ESA-naïve group.
Common treatment-emergency adverse events included nasopharyngitis and back pain.
Akizawa T, Otsuka T, Reusch M, et al. Intermittent oral dosing of roxadustat in peritoneal dialysis chronic kidney disease patients with anemia: A randomized, phase 3, multicenter, open-label study. Ther Apher Dial. 2019; published online ahead of print.