NANLING: Roxadustat Effectiveness/Safety in Chronic Kidney Disease-Associated Anemia with Peritoneal Dialysis.

INTRODUCTION

Oral anemia treatments are preferred by patients on home-based peritoneal dialysis (PD). We evaluated the effectiveness and safety of oral roxadustat in Chinese patients with chronic kidney disease (CKD)-associated anemia on PD.

METHODS

In this phase 4 study, patients with CKD-anemia on PD received roxadustat thrice weekly for 24 weeks. We assessed the proportion with hemoglobin ≥100 g/L at Weeks 20 and 24 (overall and stratified by type 2 diabetes mellitus [T2DM] vs. non-diabetes mellitus [DM]), quality of life changes according to the Functional Assessment of Cancer Therapy-Anemia (FACT-An), and 36-Item Short Form Health Survey (SF-36), and safety.

RESULTS

Overall, 195 patients (116 male [59.5%]; mean ± standard deviation age, 46.3 ± 12.3 years) were enrolled; 189 (96.9%) were erythropoiesis-stimulating agent-treated and 43 (22.1%) had T2DM. Baseline hemoglobin was 98.1 ± 10.7 g/L and was <80 g/L in 10 (5.1%). The mean (95% confidence interval) proportion who achieved a hemoglobin concentration ≥100 g/L was 85.1% (79.8%, 90.5%) (T2DM: 89.2% [78.5%, 99.9%]; non-DM: 84.0% [77.8%, 90.1%]). The change in Total FACT-An score (baseline to Week 24), but not SF-36 scores, was clinically significant (-6.2 [-9.0, -3.4]), with a greater decrease in the T2DM subgroup. Residual renal function declined slightly from baseline to Week 24 (-0.2 mL/min/1.73 m2). Treatment-emergent adverse events occurred in 158 patients (81.0%) and were roxadustat-related in 20 (10.3%).

CONCLUSION

Roxadustat corrected anemia in Chinese patients with CKD on PD, irrespective of baseline T2DM. Adverse events were consistent with roxadustat's known safety profile and with PD patients' characteristics.