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

Zhikai Yang, Tiantian Ma, Xiao Xu, Gang Fu, Jing Zhao, Ying Xu, Bin Yang, Di Song, Sainan Zhu, Jicheng Lv, Jie Dong, Zhikai Yang, Tiantian Ma, Xiao Xu, Gang Fu, Jing Zhao, Ying Xu, Bin Yang, Di Song, Sainan Zhu, Jicheng Lv, Jie Dong

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.

© 2021 International Society of Nephrology. Published by Elsevier Inc.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Flowchart of the study. Standard-dose, 100 mg and 120 mg thrice-weekly respectively for patients 50 kg, and ≤70 kg, >70 kg and ≤90 kg, and >90 kg and ≤110 kg, respectively. ∗(Reasons for patients) not meeting inclusion criteria (n = 130): PD duration <3 months (n = 20); Hb >130 g/l or <90 g/l (n = 59); weight <45 kg (n = 4); with history of malignancy (n = 1); anemia not related to CKD (n = 1); uncontrolled hypertension (n = 2); taking roxadustat or allergy to roxadustat (n = 43).
Figure 2
Figure 2
Comparison of hemoglobin responses between the standard-dose group and the low-dose group.
Figure 3
Figure 3
Comparison of actual roxadustat dose between the standard-dose group and the low-dose group. ∗P < 0.001 between the standard-dose group and the low-dose group.

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Source: PubMed

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