Roxadustat Noninferior to Epoetin Alfa in Dialysis Patients

Roxadustat is noninferior to epoetin alfa for increasing hemoglobin levels among patients with anemia who are undergoing dialysis, and is superior to placebo for patients not undergoing dialysis, according to two studies published in the issue of the New England Journal of Medicine.

Nan Chen, M.D., from the Shanghai Jiao Tong University School of Medicine, and colleagues randomly assigned patients undergoing dialysis to receive either roxadustat (204 patients) or epoetin alfa (101 patients) three times per week for 26 weeks for the treatment of anemia. A total of 256 patients (162 and 94, respectively) completed the treatment period. The researchers found that compared with epoetin alfa, roxadustat led to a numerically greater mean change in hemoglobin level from baseline to weeks 23 through 27 (0.7 ± 1.1 versus 0.5 ± 1.0 g/dL); and was statistically noninferior (difference, 0.2 ± 1.2 g/dL [95 percent confidence interval, −0.02 to 0.5]).

In a second study, Chen and colleagues randomly assigned 154 patients with anemia and chronic kidney disease who were not undergoing dialysis in a 2:1 manner to receive either roxadustat or placebo for eight weeks. The randomized phase was followed by an 18-week open-label period in which all patients received roxadustat. The researchers observed a mean change from baseline in the hemoglobin level of +1.9 ± 1.2 g/dL in the roxadustat group and −0.4 ± 0.8 g/dL in the placebo group. During the 18-week open-label period, the efficacy of roxadustat was maintained in hemoglobin correction and maintenance.

"Although roxadustat appeared to be an effective treatment option for these patients, the trials leave some unanswered questions," write the authors of an accompanying editorial.

Both studies were supported by FibroGen, the manufacturer of roxadustat.

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