Background And Hypothesis: Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved for treatment of anemia in dialysis patients with CKD in some parts of the world. This subgroup analysis examined the efficacy and safety of daprodustat versus darbepoetin alfa in patients with anemia of CKD undergoing peritoneal dialysis (PD).
Methods: ASCEND-D (NCT02879305) was an open-label, Phase 3 trial; patients with CKD were randomized to daprodustat daily and epoetin alfa (HD patients) or darbepoetin alfa (PD patients).
Nephrol Dial Transplant
October 2022
J Biopharm Stat
March 2020
Randomized clinical trials are designed to estimate the average treatment effect (ATE). If heterogeneity of treatment effect exists, then it is possible that there may be subjects who derive a treatment effect different from the ATE. We propose a method to test the hypothesis that there exist subjects who derive benefit (or harm) against the null hypothesis that the treatment has no benefit (or harm) on each of the smallest sub-populations defined by discrete baseline covariates.
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