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Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study

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Abstract

Background

Hyperphosphatemia is a common complication in dialysis patients that can be treated by oral phosphate binders. We investigated the efficacy and safety of oral ferric citrate as a phosphate binder for Taiwanese patients with end stage renal disease and with hyperphosphatemia who were undergoing hemodialysis.

Methods

This was a prospective, double-blind, placebo-controlled, randomized trial carried out in 5 hospitals in Taiwan. Ferric citrate (4 or 6 g/day) or placebo was administered for 56 days. Serum calcium, phosphorous levels, calcium × phosphorus product, serum ferritin level, transferrin saturation, and adverse events were recorded.

Results

A total of 166 patients completed the trial. The placebo group had relatively constant serum data. Serum phosphorus declined significantly in the 6 g/day group (p < 0.05 for 4 and 8 weeks) and the 4 g/day group (p < 0.05 for 4 and 8 weeks). There were similar changes in the calcium × phosphorus product. The serum ferritin level increased significantly in the 6 g/day group (p < 0.05) and the 4 g/day group (p < 0.05). There were similar changes in transferrin saturation. Most adverse events were mild to moderate and were comparable among the three groups.

Conclusions

A 56-day treatment with ferric citrate effectively controlled hyperphosphatemia and was well tolerated in maintenance hemodialysis patients. There were also moderate increases in serum ferritin and transferrin saturation.

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Acknowledgement

We would like to thank all participating investigators including Kuo CC, Wu CH, Ng HY, and Chiou YT (Chang Gung Memorial Hospital, Kaohsiung, Taiwan); Lee CC, Sun CY, Hsu HJ, and Tsai CJ (Chang Gung Medical Hospital, Keelung, Taiwan); Leu JG, and Lu LC (Shin Kong Wu Ho-Su Memorial Hospital, Taiwan); Hsu SP, Pai MF, Wu HY, and Chen HY (Far Eastern Memorial Hospital, Taiwan); Lin BS as the Medical Monitor, and Panion & BF Biotech Inc. as the sponsor of the study.

Conflict of interest

All authors have no conflict of interest to declare.

Author information

Authors and Affiliations

  1. Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, Taiwan

    Chien-Te Lee

  2. College of Medicine, Chang Gung University, Taoyuan, Taiwan

    Chien-Te Lee & I-Wen Wu

  3. Division of Nephrology, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan

    I-Wen Wu

  4. Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan

    Shou-Shan Chiang

  5. Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital, New Taipei City, Taiwan

    Yu-Sen Peng

  6. Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan

    Kuo-Hsiung Shu & Ming-Ju Wu

  7. Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital, 252 Wusing Street, Taipei, Taiwan

    Mai-Szu Wu

  8. Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan

    Mai-Szu Wu

Authors
  1. Chien-Te Lee
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  2. I-Wen Wu
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  3. Shou-Shan Chiang
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  4. Yu-Sen Peng
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  5. Kuo-Hsiung Shu
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  7. Mai-Szu Wu
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Corresponding author

Correspondence to Mai-Szu Wu.

Additional information

ClinicalTrials.gov; identifier: NCT01503736.

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Lee, CT., Wu, IW., Chiang, SS. et al. Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study. J Nephrol 28, 105–113 (2015). https://doi.org/10.1007/s40620-014-0108-6

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  • DOI: https://doi.org/10.1007/s40620-014-0108-6

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