Daprodustat vs Vadadustat

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.

NCT02648347 · Phase 3 · completed

Participants were randomized to vadadustat or active treatment with darbepoetin alfa, but the trial was open-label; 879 received vadadustat and 872 received darbepoetin alfa. The hemoglobin primary endpoint met the prespecified non-inferiority criterion, while the primary cardiovascular safety comparison did not, making the findings mixed rather than clearly positive.