AND017 vs Daprodustat

NCT05265325 · Phase 2 · completed

The study was randomized, triple-blind, and active-controlled, with 175 participants assigned to AND017 or standard erythropoiesis-stimulating therapy. However, the registry does not report whether the primary endpoints—adverse-event incidence and mean hemoglobin change at Week 6—were met, so the findings cannot be judged as demonstrating a positive effect.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

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.