Phase 3 Study of Roxadustat to Treat Anemia in Non-Dialysis-Dependant CKD.

ABSTRACT:

Introduction

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).

Methods

This was a phase III, active-controlled, multicenter, partially randomized, open-label study in Japanese patients with NDD CKD. Patients who had used recombinant human erythropoietin or darbepoetin alfa (DA) before conversion were randomized to roxadustat or DA (comparative arms). Patients who had used epoetin beta pegol before conversion were allocated to roxadustat (reference arm). The primary endpoint was change in average hemoglobin (Hb) level from baseline during the evaluation period (Weeks 18-24). Longer term e

SUBMITTER: Akizawa T 

PROVIDER: S-EPMC8258605 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature