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

Abstract

OBJECTIVES:

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).

METHODS:

This is a single center, before and after treatment, self-controlled study; 55 CAPD patients with renal anemia and EPO 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 and tumor necrosis factor-α levels via enzyme linked immunosorbent assay. The Modified Quantitative Subjective Global Assessment Score and Malnutrition-Inflammation Score before and after treatment, and adverse events during treatment were recorded. The follow-up observation time was 12 weeks. Preliminary data 12-24 weeks before the enrollment as well as post-follow-up data at 36 weeks were also collected.

RESULTS:

Fifty patients completed the 12-week follow-up. The hemoglobin levels were 8.0 ± 1.2 g/dL at baseline and 11.2 ± 2.0 g/dL after 12 weeks 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 ≥ 1.0 g/dL) was 80%, and 50% of the patients reached the hemoglobin target (hemoglobin ≥ 11.0 g/dL) at 12 weeks. Transferrin was higher at 12 weeks (2.2 ± 0.5 g/L) than at baseline (1.7 ± 0.5 g/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, were not 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 Score and Malnutrition-Inflammation Score were slightly lower at 12 weeks 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 12 weeks resulted in a decreased hemoglobin at 36 weeks.

CONCLUSIONS:

In patients with EPO hyporesponsiveness on CAPD, roxadustat can efficiently and safely improve anemia and nutritional status without promoting inflammation.

• Authors: Junjie Chen, Zhi Li, Hao Zhang, Jing Hu, Jianwen Wang, Huang Zhou, Yan Liu, Jun Liu, Bin Yi, Wei Zhang
• Journal: Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation (J Ren Nutr) Vol. 32 Issue 5 Pg. 595-604 (09 2022) ISSN: 1532-8503 [Electronic] United States
• PMID: 34756787 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Hemoglobins
• Interleukin-6
• Isoquinolines
• Tumor Necrosis Factor-alpha
• Erythropoietin
• C-Reactive Protein
• Glycine
• roxadustat

Topics

• Anemia (drug therapy, etiology)
• C-Reactive Protein (metabolism)
• Erythropoietin (therapeutic use)
• Glycine (analogs & derivatives)
• Hemoglobins (metabolism)
• Humans
• Inflammation
• Interleukin-6
• Isoquinolines
• Malnutrition
• Peritoneal Dialysis
• Pilot Projects
• Prospective Studies
• Renal Dialysis
• Tumor Necrosis Factor-alpha