Pooled Analysis of Roxadustat for Anemia in Patients With Kidney Failure Incident to Dialysis.

ABSTRACT:

Introduction

Erythropoiesis-stimulating agents are associated with increased cardiovascular risk when higher doses are used toward higher hematocrit targets. Patients new to dialysis are at higher risk for morbidity and mortality. Systematic evaluation of this population was predefined in the roxadustat clinical development program. Roxadustat is a hypoxia-inducible prolyl hydroxylase inhibitor.

Methods

Data were pooled from 3 phase 3, randomized, open-label, active-controlled trials. Eligible adults had kidney failure and initiated dialysis for 2 weeks to ≤ 4 months prior to randomization to roxadustat or epoetin alfa. Efficacy was assessed as mean change in hemoglobin from baseline averaged over weeks 28 to 52, regardless of rescue therapy. Key cardiovascular safety endpoi

SUBMITTER: Provenzano R 

PROVIDER: S-EPMC7938204 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature