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Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD.
Clin J Am Soc Nephrol. 2014 Mar; 9(3):543-52.CJ

Abstract

BACKGROUND AND OBJECTIVES

Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS

A phase 3, multicenter, randomized, double blind, placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD. Starting in April of 2011, 90 CKD patients (eGFR=9.21±5.72 ml/min per 1.73 m(2)) with a serum phosphate≥5.0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks. The primary end point was change in serum phosphate from baseline to the end of treatment. Secondary end points included the percentage of patients achieving target serum phosphate levels (2.5-4.5 mg/dl) and change in fibroblast growth factor-23 at the end of treatment.

RESULTS

The mean change in serum phosphate was -1.29 mg/dl (95% confidence interval, -1.63 to -0.96 mg/dl) in the ferric citrate hydrate group and 0.06 mg/dl (95% confidence interval, -0.20 to 0.31 mg/dl) in the placebo group (P<0.001 for difference between groups). The percentage of patients achieving target serum phosphate levels was 64.9% in the ferric citrate hydrate group and 6.9% in the placebo group (P<0.001). Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo (change from baseline [median], -142.0 versus 67.0 pg/ml; P<0.001). Ferric citrate hydrate significantly increased serum iron, ferritin, and transferrin saturation compared with placebo (P=0.001 or P<0.001). Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo. Overall, adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo, with gastrointestinal disorders occurring in 30.0% of ferric citrate hydrate patients and 26.7% of patients receiving placebo.

CONCLUSION

In patients with nondialysis-dependent CKD, 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters.

Authors+Show Affiliations

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan;, †Japanese Red Cross, Fukuoka Hospital, Fukuoka, Japan;, ‡Department of Blood Purification, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan;, §Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan;, ‖Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism, Fukushima Medical University School of Medicine, Fukushima, Japan;, ¶Department of Hematology, Nephrology and Rheumatology, Akita University, Akita, Japan;, *Kitasato University East Hospital Clinical Trial Center, Sagamihara, Japan, ††Denver Nephrologists, PC, Denver, Colorado.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24408120

Citation

Yokoyama, Keitaro, et al. "Ferric Citrate Hydrate for the Treatment of Hyperphosphatemia in Nondialysis-dependent CKD." Clinical Journal of the American Society of Nephrology : CJASN, vol. 9, no. 3, 2014, pp. 543-52.
Yokoyama K, Hirakata H, Akiba T, et al. Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. Clin J Am Soc Nephrol. 2014;9(3):543-52.
Yokoyama, K., Hirakata, H., Akiba, T., Fukagawa, M., Nakayama, M., Sawada, K., Kumagai, Y., & Block, G. A. (2014). Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. Clinical Journal of the American Society of Nephrology : CJASN, 9(3), 543-52. https://doi.org/10.2215/CJN.05170513
Yokoyama K, et al. Ferric Citrate Hydrate for the Treatment of Hyperphosphatemia in Nondialysis-dependent CKD. Clin J Am Soc Nephrol. 2014;9(3):543-52. PubMed PMID: 24408120.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. AU - Yokoyama,Keitaro, AU - Hirakata,Hideki, AU - Akiba,Takashi, AU - Fukagawa,Masafumi, AU - Nakayama,Masaaki, AU - Sawada,Kenichi, AU - Kumagai,Yuji, AU - Block,Geoffrey A, Y1 - 2014/01/09/ PY - 2014/1/11/entrez PY - 2014/1/11/pubmed PY - 2014/11/11/medline SP - 543 EP - 52 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 9 IS - 3 N2 - BACKGROUND AND OBJECTIVES: Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A phase 3, multicenter, randomized, double blind, placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD. Starting in April of 2011, 90 CKD patients (eGFR=9.21±5.72 ml/min per 1.73 m(2)) with a serum phosphate≥5.0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks. The primary end point was change in serum phosphate from baseline to the end of treatment. Secondary end points included the percentage of patients achieving target serum phosphate levels (2.5-4.5 mg/dl) and change in fibroblast growth factor-23 at the end of treatment. RESULTS: The mean change in serum phosphate was -1.29 mg/dl (95% confidence interval, -1.63 to -0.96 mg/dl) in the ferric citrate hydrate group and 0.06 mg/dl (95% confidence interval, -0.20 to 0.31 mg/dl) in the placebo group (P<0.001 for difference between groups). The percentage of patients achieving target serum phosphate levels was 64.9% in the ferric citrate hydrate group and 6.9% in the placebo group (P<0.001). Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo (change from baseline [median], -142.0 versus 67.0 pg/ml; P<0.001). Ferric citrate hydrate significantly increased serum iron, ferritin, and transferrin saturation compared with placebo (P=0.001 or P<0.001). Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo. Overall, adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo, with gastrointestinal disorders occurring in 30.0% of ferric citrate hydrate patients and 26.7% of patients receiving placebo. CONCLUSION: In patients with nondialysis-dependent CKD, 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/24408120/Ferric_citrate_hydrate_for_the_treatment_of_hyperphosphatemia_in_nondialysis_dependent_CKD_ L2 - https://cjasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=24408120 DB - PRIME DP - Unbound Medicine ER -