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Safety Profile of Roxadustat in Anemic Patients: A Meta-Analysis of 21 RCTs
Lokman Hekim Tanriverdi1, Ahmet Sarici2, Mehmet Ali Erkurt2
1Inonu University Faculty of Medicine, Department of Medical Pharmacology, Malatya, Türkiye.
Medeniyet Medical Journal
|January 2, 2026
Summary
Roxadustat, an oral treatment for anemia in chronic kidney disease, shows a safety profile comparable to erythropoiesis-stimulating agents (ESAs). While hyperkalemia and withdrawals due to adverse events were more frequent, overall mortality was lower than placebo.
Area of Science:
- Nephrology
- Pharmacology
- Clinical Trials
Background:
- Anemia is a common complication in patients with chronic kidney disease (CKD).
- Roxadustat offers an oral alternative to injectable erythropoiesis-stimulating agents (ESAs) for anemia management.
- Understanding the safety and tolerability of roxadustat is crucial for clinical practice.
Purpose of the Study:
- To conduct a meta-analysis of randomized controlled trials (RCTs) to assess the safety and tolerability of roxadustat.
- To compare the risk of serious treatment-emergent adverse events (TEAEs) between roxadustat and control groups (placebo or ESAs).
Main Methods:
- Systematic literature search of major databases (Cochrane CENTRAL, Medline, PubMed, Web of Science) up to January 2025.
- Inclusion of 21 RCTs involving 11,686 patients comparing roxadustat with placebo or ESAs.
- Utilized inverse-variance-weighted random-effects models for meta-analysis, focusing on TEAEs and subgroup analyses.
Main Results:
- Roxadustat did not increase the risk of serious TEAEs compared to placebo or ESAs.
- Hyperkalemia was more frequent with roxadustat versus placebo, but not ESA.
- Withdrawals due to adverse events were higher with roxadustat compared to ESAs; all-cause mortality was lower than placebo and comparable to ESAs.
Conclusions:
- Roxadustat exhibits a safety profile generally comparable to ESAs, with no significant differences in major adverse cardiovascular events.
- Increased incidence of hyperkalemia and treatment withdrawals necessitates careful patient monitoring.
- The findings support the non-inferiority of roxadustat to ESAs regarding safety in treating anemia in CKD patients.
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