Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non-Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO

Authors

Wolfgang C Winkelmayer
Susan Arnold
Steven K Burke
Glenn M Chertow
Kai-Uwe Eckardt
Alan G Jardine
Eldrin F Lewis
Wenli Luo
Kunihiro Matsushita
Peter A McCullough
Todd Minga
Patrick S Parfrey

Publication Date

7-1-2023

Journal

Kidney Medicine

DOI

10.1016/j.xkme.2023.100666

PMID

37427293

PMCID

PMC10329162

PubMedCentral® Posted Date

5-12-2023

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Anemia, chronic kidney disease, hypoxia-inducible factor, vadadustat, darbepoetin alfa

Abstract

RATIONALE & OBJECTIVE: Prespecified analyses of the PRO

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

SETTING AND PARTICIPANTS: Erythropoiesis-stimulating agent-untreated patients with anemia and NDD-CKD.

INTERVENTION: Eligible patients were randomized 1:1 to receive vadadustat or darbepoetin alfa.

OUTCOMES: The primary safety end point was time to first MACE. Secondary safety end points included time to first expanded MACE (MACE plus hospitalization for heart failure or thromboembolic event, excluding vascular access thrombosis).

RESULTS: In the non-US/non-Europe region, there was a higher proportion of patients with baseline estimated glomerular filtration rate (eGFR) level of ≤10 mL/min/1.73 m

LIMITATIONS: Different regional treatment patterns of patients with NDD-CKD.

CONCLUSIONS: The higher MACE rate in the non-US/non-Europe vadadustat group may have been partly because of imbalances in the baseline eGFR level in countries where dialysis was not uniformly available resulting in many kidney-related deaths.

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