Roxadustat acts as a HIF prolyl-hydroxylase inhibitor and increases the endogenous production of erythropoietin and stimulates the production of hemoglobin in red blood cells. The objective of this study is to evaluate the safety and efficacy of oral roxadustat in CKD patients with anemia on hemodialysis.
This randomized, double-blind, active-comparator, phase 3 trial included a total of 303 CKD patients with anemia who were on hemodialysis. The patients were randomly assigned in a 1:1 ratio to oral roxadustat three times weekly (n=151) or darbepoetin alfa injections once weekly (n=152). The primary outcome of the study was a change in the overall hemoglobin levels from baseline.
At 18-24 weeks of evaluation, the difference in hemoglobin levels between roxadustat and darbepoetin alfa was −0.02 g/dl. The average hemoglobin at 18-24 weeks with roxadustat was 10.99 g/dl. In patients with one or more hemoglobin values during weeks 18-24, the maintenance rate was 95.2% with roxadustat and 91.3% with darbepoetin alfa. Commonly occurring treatment-related adverse events in both groups were shunt stenosis, diarrhea, nasopharyngitis, vomiting, and confusion.
The research concluded that roxadustat was non-inferior to darbepoetin alfa in improving blood hemoglobin levels from the baseline. Besides, roxadustat also maintained 10–12 g/dl hemoglobin in patients on hemodialysis.