Research AppraisalSystematic Review

Roxadustat for CKD-related anemia in patients undergoing peritoneal dialysis: a systematic review and meta-analysis

BMC nephrologyElkoumi, Omar, Elkoumi, Ahmed, Elbairy, Mariam Khaled et al.25 May 2026DOI

Clinical Snapshot

80CEBM
Evidence: ModerateSystematic Review

PICO Framework

P — PopulationPatients with chronic kidney disease-related anemia undergoing peritoneal dialysis
I — InterventionRoxadustat (oral hypoxia-inducible factor prolyl hydroxylase inhibitor)
C — ComparatorControl groups (likely placebo or standard care with erythropoiesis-stimulating agents)
O — OutcomesHemoglobin levels, iron metabolism parameters (serum iron, TIBC, hepcidin, ferritin, transferrin saturation), lipid profile, inflammatory markers, blood pressure

Bottom Line

This meta-analysis of 607 peritoneal dialysis patients demonstrates that roxadustat produces statistically significant but modest improvements in hemoglobin levels (0.35 g/dL increase) and iron metabolism parameters. The oral convenience represents a potential advantage over injectable erythropoiesis-stimulating agents. However, the clinical significance of this hemoglobin increase is questionable, and the evidence base remains limited with only 8 studies. Safety profile appears neutral for cardiovascular and metabolic parameters. While promising, the evidence is insufficient to definitively establish roxadustat as superior to current standard care. Australian nephrologists should await larger, longer-term randomised controlled trials and regulatory approval before considering routine clinical use. The drug may have particular utility in patients intolerant of or refractory to conventional ESA therapy.

Evidence: Moderate

Key Findings

  • P Value: p < 0.00001 for hemoglobin improvement

  • Effect Size: Small to moderate clinical effect

  • Primary Outcome: Hemoglobin increase of 0.35 g/dL (95% CI 0.28-0.41)

  • Nnt Or Sensitivity: Clinically meaningful hemoglobin response likely in majority of treated patients based on confidence interval

  • Confidence Interval: 95% CI 0.28-0.41 g/dL for hemoglobin

Clinical Application

Oral administration offers practical advantage over injectable ESAs; requires monitoring of iron parameters and cardiovascular safety Would require TGA approval; potential PBS listing consideration given oral convenience; aligns with ANZDATA registry focus on PD outcomes; relevant to RACGP chronic disease management Australian peritoneal dialysis patients with CKD-related anemia, particularly those intolerant or refractory to erythropoiesis-stimulating agents

Abstract

BACKGROUND: CKD-related anemia remains a major complication in patients receiving peritoneal dialysis (PD), with limited treatment options beyond erythropoiesis-stimulating agents. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, has shown promise in correcting CKD-related anemia and modulating iron and metabolic parameters. However, its evidence in PD remains limited. METHODS: We conducted a systematic search of PubMed, Scopus, and Web of Science from inception to July 20, 2025. We included studies reporting the efficacy and safety of roxadustat in PD. Statistical analysis was performed using Review Manager (RevMan 5.4 for Windows) and R Studio. RESULTS: Eight studies were included in the meta-analysis (n = 607). Roxadustat significantly increased hemoglobin at all time points (MD 0.35 g/dL, 95% CI 0.28-0.41; p < 0.00001), serum iron (MD 0.95 µmol/L, 95% CI 0.02-1.89; p = 0.05), and total iron-binding capacity (MD 6.25 µmol/L, 95% CI 3.95-8.55; p < 0.00001), and reduced hepcidin (MD - 12.28 ng/mL, 95% CI - 21.06 to - 3.50; p = 0.006). No significant effects were observed for ferritin (p = 0.49), transferrin saturation (p = 0.45), cholesterol (p = 0.07), LDL (p = 0.14), HDL (p = 0.27), triglycerides (p = 0.26), CRP (p = 0.75), systolic blood pressure (p = 0.10), or diastolic blood pressure (p = 0.08). Heterogeneity was low to moderate for most outcomes. CONCLUSION: Roxadustat is effective in improving hemoglobin and iron metabolism in patients with PD, while exerting neutral effects on lipids, inflammation, and blood pressure. These findings support its role as a promising therapy for CKD-related anemia in PD. CLINICAL TRIAL NUMBER: Not applicable.

References

  1. 1.Elkoumi, O., Elkoumi, A., Elbairy, M. K., Mahmoud, M. A. T., & Irfan, H. (2026). Roxadustat for CKD-related anemia in patients undergoing peritoneal dialysis: a systematic review and meta-analysis. BMC Nephrology. https://doi.org/10.1016/j.amjcard.2025.07.010
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