Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non - Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO 2 TECT Randomized Clinical Trial of ESA-Treated Patients

In the PRO TECT 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...

Full description

Saved in:
Bibliographic Details
Published in:Kidney medicine 2023-07, Vol.5 (7), p.100667
Main Authors: Parfrey, Patrick S, Burke, Steven K, Chertow, Glenn M, Eckardt, Kai-Uwe, Jardine, Alan G, Lewis, Eldrin F, Luo, Wenli, Matsushita, Kunihiro, McCullough, Peter A, Minga, Todd, Winkelmayer, Wolfgang C
Format: Article
Language:English
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:In the PRO TECT 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 PRO TECT trials. Phase 3, global, open-label, randomized, active-controlled clinical trial. A total of 1,725 erythropoiesis-stimulating agent (ESA)-treated patients with anemia and NDD-CKD. 1:1 randomization to receive vadadustat or darbepoetin alfa. The primary safety end point was the time to first MACE. At baseline, patients in Europe (n=444) were primarily treated with darbepoetin alfa, showed higher proportions on low ESA doses (
ISSN:2590-0595