Randomized Trial of Lower-Dose Roxadustat Efficacy and Safety in Non-Dialysis-Dependent CKD-Associated Anemia.

ABSTRACT:

Introduction

Different starting doses of roxadustat are used for treating anemia in chronic kidney disease (CKD). We tested the noninferiority of weight-based lower starting dose compared with standard starting dose roxadustat for anemia in stage 3 to 5 CKD without dialysis.

Methods

Patients were randomized (1:1) and stratified by CKD stage to receive weight-based standard (< 60 kg: 70 mg 3 times per week [TIW]; ≥ 60 kg: 100 mg TIW) or 1-step-lower (< 60 kg: 50 mg TIW; ≥ 60 kg: 70 mg TIW) roxadustat starting dose for 16 weeks. The primary endpoint was mean hemoglobin change from baseline over weeks 12 to 16. The secondary endpoints included the proportion achieving hemoglobin 100 to 120 g/l, hemoglobin variability, and rescue therapy.

Results

Overall, 254 patients wer

SUBMITTER: Li P 

PROVIDER: S-EPMC12034882 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature