Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT: INTRODUCTION:This study evaluated efficacy and safety/tolerability of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese anemic non-dialysis-dependent chronic kidney disease (NDD-CKD) patients. METHODS:In this phase 2, double-blind, 24-week study, NDD-CKD patients were randomized to oral placebo or roxadustat (50, 70, or 100 mg) three times weekly (TIW) for 6 weeks followed by dose adjustments to maintain hemoglobin (Hb) at 10-12 g/dL for 18 weeks; patients meeting pre-defined criteria were re-randomized to TIW or once-weekly dosing. The primary end point was rate of rise of Hb (g/dL/week) during the first 6 weeks; secondary end points included response rate (Hb???10.0 g/dL and increase in Hb from baseline???1 g/dL) and mean Hb and change from baseline in Hb at weeks 18-24. The main safety outcomes were vital signs, laboratory test results, electrocardiograms, and frequency of treatment-emergent adverse events. RESULTS:Of 107 patients randomized, 83 completed the study. The mean (SD) rate of rise of Hb during the first 6 weeks was -?0.052 (0.142) for placebo and +?0.200 (0.160), +?0.453 (0.256), and +?0.570 (0.240) for roxadustat 50-, 70-, and 100-mg TIW groups, respectively (p?

SUBMITTER: Akizawa T 

PROVIDER: S-EPMC6824366 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature