Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis

Abstract

Introduction: We aimed to investigate whether a lower starting dose of roxadustat (∼1–1.4 mg/kg) converted from erythropoiesis-stimulating agent (ESA) could achieve a comparable hemoglobin (Hb) target (≥100 and ≤120 g/l) compared with the standard weight-based dose (∼1.5–2 mg/kg) at week 12 through a peritoneal dialysis (PD) cohort. Methods: A 12-week multicenter randomized, parallel-controlled, open-label, pilot clinical trial enrolled adult patients who had undergone PD treatment for >3 months with renal anemia. Participants were randomized in blocks of 4 in a 1:1 ratio to either the standard-dose group (n = 50) or the low-dose group (n = 50). The primary end point was the proportion of patients achieving the Hb target at week 12. Results: Baseline demographic and clinical characteristics of the 2 groups were comparable. There was no difference in the proportion of patients who met the Hb target at week 12, that is, 26 patients (52%) versus 31 patients (62%) in the low-dose group and standard-dose group, respectively (P = 0.31). The Hb levels significantly increased in both groups from baseline to week 12; the median change of Hb levels was 5.0 (0.0–14.3) g/l (P < 0.001) for the standard-dose group and 6.0 (−3.3 to 16.3) g/l for the low-dose group (P = 0.005) (P = 0.581 for between groups). Conclusion: This study suggests that a lower starting dose of roxadustat effectively achieves the Hb target as standard-dose does among patients on PD. (ClinicalTrials.gov number, NCT04454879).

Keywords

• hypoxia-inducible factor prolyl hydroxylase inhibitor
• peritoneal dialysis
• renal anemia
• roxadustat