Lower starting dose of roxadustat in non-dialysis-dependent chronic kidney disease patients with anaemia: a study protocol for a randomised, multicentre, open-label study.

ABSTRACT:

Introduction

Roxadustat is a first-in-class oral therapy that treats chronic kidney disease (CKD) anaemia with the benefit of a novel mechanism of action that consistently corrects and maintains haemoglobin (Hb) across the spectrum of non-dialysis-dependent (NDD) CKD anaemia with an acceptable safety profile.

Methods and analysis

This is a randomised, control, open-label, multicentre trial. About 250 adult Chinese participants with stage 3-5 CKD NDD in approximately 30 centres will be enrolled, randomly assigned in a 1:1 ratio, to receive a 16-week treatment and 4-week follow-up. The interventions for study arm are <60 kg: 50 mg TIW and ≥60 kg: 70 mg TIW; for control arm, <60 kg: 70 mg TIW and ≥60 kg: 100 mg TIW. The primary endpoint is the mean change in haemoglobin level f

SUBMITTER: Li P 

PROVIDER: S-EPMC9923260 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature