Efficacy and safety of ferric citrate tablets in Chinese patients with hyperphosphatemia undergoing maintenance hemodialysis: a multicenter, randomized, open-label, active-controlled, phase III trial.
Jie Ma, Bicheng Liu, Jialiang Pang et al.
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In 30 seconds
This phase III, multicenter, randomized, open-label trial evaluated the efficacy and safety of ferric citrate tablets in 239 Chinese patients with hyperphosphatemia undergoing maintenance hemodialysis. Ferric citrate demonstrated non-inferiority to sevelamer carbonate in reducing serum phosphorus levels, with a mean change of -0.70 ± 0.50 mmol/L compared to -0.61 ± 0.59 mmol/L for sevelamer carbonate.
Key findings
- Ferric citrate reduced serum phosphorus by -0.70 ± 0.50 mmol/L, while sevelamer carbonate reduced it by -0.61 ± 0.59 mmol/L.
- The least squares mean difference in phosphorus reduction was -0.09 mmol/L, within the non-inferiority margin of 0.32 mmol/L.
- 49.09% of patients on ferric citrate achieved target phosphorus levels compared to 48.28% on sevelamer carbonate.
- Ferric citrate improved iron-related parameters and hemoglobin levels.
Why it matters
The findings suggest that ferric citrate is an effective alternative to sevelamer carbonate for managing hyperphosphatemia in hemodialysis patients, with additional benefits for iron status and hemoglobin levels, which are critical in this population.