NANLING：透析患者における慢性腎臓病関連貧血に対するロキサデュスタットの有効性・安全性

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.

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.

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%).

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.