Daprodustat vs Desidustat

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.

NCT04012957 · Phase 3 · completed

The study was randomized and used an active darbepoetin comparator, but it was open-label and its primary outcome was change in hemoglobin, a surrogate laboratory measure rather than a hard clinical or endoscopic outcome. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.