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Efficacy and Safety of Ferric Citrate on Hyperphosphatemia among Chinese Patients with Chronic Kidney Disease
Yong Wang1, Xiangmei Chen, Hanyu Zhu1
1Department of Nephrology, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, China.
Insights
Ferric citrate effectively controls hyperphosphatemia in hemodialysis patients, showing comparable efficacy to sevelamer carbonate. This phosphorus binder also improved iron metabolism with manageable side effects.
Area of Science:
- Nephrology
- Pharmacology
- Internal Medicine
Background:
- Hyperphosphatemia is a significant mortality risk factor in chronic kidney disease (CKD) patients.
- Effective phosphorus binders are crucial for managing CKD complications.
- Ferric citrate offers a dual benefit of phosphorus binding and iron metabolism improvement.
Purpose of the Study:
- To compare the efficacy and safety of ferric citrate versus sevelamer carbonate in Chinese hemodialysis patients.
- To evaluate the impact of ferric citrate on serum phosphorus, calcium, and iron metabolism.
- To assess the incidence and nature of adverse events associated with ferric citrate.
Main Methods:
- A randomized controlled trial involving Chinese hemodialysis patients.
- Patients were assigned to receive either ferric citrate or sevelamer carbonate for 12 weeks.
- Serum phosphorus, calcium, intact-PTH, and iron metabolism parameters were monitored bi-weekly; adverse events were recorded.
Main Results:
- Ferric citrate achieved comparable serum phosphorus reduction to sevelamer carbonate (0.59 vs. 0.56 mmol/L).
- No significant differences were observed in achieving target phosphorus levels, response rates, or changes in calcium and PTH.
- Ferric citrate demonstrated significant improvements in iron metabolism indicators compared to sevelamer carbonate.
- Drug-related adverse events were mostly mild and tolerable, with gastrointestinal issues being most common.
Conclusions:
- Ferric citrate is effective and safe for managing hyperphosphatemia in hemodialysis patients.
- Its efficacy is non-inferior to sevelamer carbonate.
- Ferric citrate presents a favorable option, particularly due to its positive effects on iron metabolism.
Introduction:
Hyperphosphatemia in chronic kidney disease (CKD) patients is positively associated with mortality. Ferric citrate is a potent phosphorus binder that lowers serum phosphorus level and improves iron metabolism. We compared its efficacy and safety with active drugs in Chinese CKD patients with hemodialysis.
Methods:
Chinese patients undergoing hemodialysis were randomized into two treatment groups in a 1:1 ratio, receiving either ferric citrate or sevelamer carbonate, respectively, for 12 weeks. Serum phosphorus levels, calcium concentration, and iron metabolism parameters were evaluated every 2 weeks. Frequency and severity of adverse events were recorded.
Results:
217 (90.4%) patients completed the study with balanced demographic and baseline characteristics between two groups. Ferric citrate decreased the serum phosphorus level to 0.59 ± 0.54 mmol/L, comparable to 0.56 ± 0.62 mmol/L by sevelamer carbonate. There was no significant difference between two groups (p > 0.05) in the proportion of patients with serum phosphorus levels reaching the target range, the response rate to the study drug, and the changes of corrected serum calcium concentrations, and intact-PTH levels at the end of treatment. The change of iron metabolism indicators in the ferric citrate group was significantly higher than those in the sevelamer carbonate group. There are 47 (40.5%) patients in the ferric citrate group, and 26 (21.3%) patients in the sevelamer carbonate group experienced drug-related treatment emergent adverse events (TEAEs); most were mild and tolerable. Common drug-related TEAEs were gastrointestinal disorders, including diarrhea (12.9 vs. 2.5%), fecal discoloration (14.7 vs. 0%), and constipation (1.7 vs. 7.4%) in ferric citrate and sevelamer carbonate group.
Conclusion:
Ferric citrate capsules have good efficacy and safety in the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis. Efficacy is not inferior to sevelamer carbonate. The TEAEs were mostly mild and tolerated by the patients.
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