Daprodustat vs Roxadustat

NCT02876835 · Phase 3 · completed

This was a large randomized Phase 3 trial comparing oral daprodustat with darbepoetin alfa in 3,872 non-dialysis chronic kidney disease patients with anemia, conducted open-label — neither participants nor investigators were blinded to assignment. Although the active-comparator design was otherwise robust, the two pre-specified non-inferiority primary endpoints were both achieved: time to MACE (HR 1.03; 95% CI 0.89–1.19, within the 1.25 margin) and change in hemoglobin over weeks 28–52 (LS mean difference 0.08 g/dL; 95% CI 0.03–0.13, within the -0.75 g/dL margin). Because the trial was not blinded, this is solid but not top-tier evidence; secondary superiority analyses of cardiovascular outcomes were not statistically significant.

NCT01750190 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled Phase 3 trial in 922 non-dialysis CKD patients with anemia. The two primary efficacy endpoints—mean change in hemoglobin over weeks 28-52 and hemoglobin response during the first 24 weeks—were both statistically significant and strongly favored roxadustat over placebo (p<0.0001 for both). The study was adequately powered and used a hard hemoglobin-based clinical endpoint, supporting a strong design and result.