Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non-Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO₂TECT Randomized Clinical Trial of ESA-Treated Patients.

ABSTRACT:

Rationale & objective

In the PRO₂TECT trials, vadadustat was found to be noninferior to darbepoetin alfa in hematologic efficacy but not for major adverse cardiovascular events (MACE; all-cause death or nonfatal myocardial infarction or stroke) in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). We investigated the regional differences in MACE in the PRO₂TECT trials.

Study design

Phase 3, global, open-label, randomized, active-controlled clinical trial.

Setting & participants

A total of 1,725 erythropoiesis-stimulating agent (ESA)-treated patients with anemia and NDD-CKD.

Intervention

1:1 randomization to receive vadadustat or darbepoetin alfa.

Outcomes

The primary safety end point was the time to first MACE.

SUBMITTER: Parfrey PS 

PROVIDER: S-EPMC10329165 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature