A Prospective, Self-Controlled Pilot Study of the Efficacy of Roxadustat for Erythropoietin Hyporesponsiveness in Patients Requiring Chronic Ambulatory Peritoneal Dialysis

Abstract

The present study aimed to explore the efficacy and safety of roxadustat in patients with renal anemia and erythropoietin (EPO) hyporesponsive who are receiving continuous ambulatory peritoneal dialysis (CAPD). This is a single center, before and after treatment, self-controlled study; 55 CAPD patients with renal anemia andEPO hyporesponsiveness were enrolled. The main follow-up parameters included routine blood, liver and kidney function, electrolyte, blood lipid, high-sensitivity C-reactive protein, and iron tests. Serum samples were used to determine interleukin-6 andtumor necrosis factor-α levels via enzyme linked immunosorbent assay. The Modified Quantitative Subjective Global Assessment Score and Malnutrition-Inflammation Scorebefore and after treatment, and adverse events during treatment were recorded. The follow-up observation time was12weeks. Preliminary data 12-24weeks before the enrollment as well as post-follow-up data at 36weeks were also collected. Fifty patients completed the 12-week follow-up. The hemoglobin levels were 8.0±1.2g/dL at baseline and 11.2±2.0g/dL after 12weeks of roxadustat treatment. The hemoglobin increases at all measured time points and was statistically significant compared with the baseline value (P<.05). The overall hemoglobin response rate (hemoglobin increase ≥1.0g/dL) was 80%, and 50% of the patients reached the hemoglobin target (hemoglobin ≥ 11.0g/dL) at 12weeks. Transferrin was higher at 12weeks (2.2±0.5g/L) than at baseline (1.7±0.5g/L) (P<.05), while serum ferritin levels slightly decreased compared with the baseline value (P>.05). The median high-sensitivity C-reactive protein level and other inflammation-related indicators, such as white blood cell counts, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, interleukin-6, and tumor necrosis factor-α,werenot significantly different from their baseline values. Nutrition-related biochemical indices such as albumin, creatinine, and blood lipids were also not significantly changed. The Modified Quantitative Subjective Global Assessment ScoreandMalnutrition-Inflammation Score were slightly lower at 12weeks than at baseline. No serious adverse events were observed during the follow-up period. Post-follow-up data revealed a maintained hemoglobin level in patients who remained on roxadustat treatment while those switched back to EPO treatment after 12weeks resulted in a decreased hemoglobin at 36weeks. In patients with EPO hyporesponsiveness on CAPD, roxadustat can efficiently and safely improve anemia and nutritional status without promoting inflammation.