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J Am Soc Nephrol. 2015 Oct;26(10):2578-87. doi: 10.1681/ASN.2014080842. Epub 2015 Mar 3.

Ferric Citrate Reduces Intravenous Iron and Erythropoiesis-Stimulating Agent Use in ESRD.

Author information

1
Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan; kumanat1@hfhs.org.
2
Renal Diseases and Hypertension, University of Colorado, Denver, Colorado;
3
Western New England Renal and Transplant Associates, Baystate Medical Center, Springfield, Massachusetts;
4
Divisions of Nephrology and Hypertension and.
5
Section of Nephrology and Hypertension, Louisiana State University Health Science Center, New Orleans, Louisiana;
6
Mountain Kidney and Hypertension Associates, Asheville, North Carolina;
7
Pines Clinical Research, Pembroke Pines, Florida;
8
Division of Nephrology, University of Vermont, Burlington, Vermont;
9
Nephrology and Hypertension Clinic, Southgate, Michigan;
10
Division of Nephrology, Medical College of Wisconsin, Milwaukee, Wisconsin;
11
Independent Consultant, Pocono Pines, Pennsylvania; and.
12
Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee;
13
Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.

Abstract

Ferric citrate (FC) is a phosphate binder with shown efficacy and additional effects on iron stores and use of intravenous (iv) iron and erythropoiesis-stimulating agents (ESAs). We provide detailed analyses of changes in iron/hematologic parameters and iv iron/ESA use at time points throughout the active control period of a phase 3 international randomized clinical trial. In all, 441 subjects were randomized (292 to FC and 149 to sevelamer carbonate and/or calcium acetate [active control (AC)]) and followed for 52 weeks. Subjects on FC had increased ferritin and transferrin saturation (TSAT) levels compared with subjects on AC by week 12 (change in ferritin, 114.1±29.35 ng/ml; P<0.001; change in TSAT, 8.62%±1.57%; P<0.001). Change in TSAT plateaued at this point, whereas change in ferritin increased through week 24, remaining relatively stable thereafter. Subjects on FC needed less iv iron compared with subjects on AC over 52 weeks (median [interquartile range] dose=12.9 [1.0-28.9] versus 26.8 [13.4-47.6] mg/wk; P<0.001), and the percentage of subjects not requiring iv iron was higher with FC (P<0.001). Cumulative ESA over 52 weeks was lower with FC than AC (median [interquartile range] dose=5303 [2023-9695] versus 6954 [2664-12,375] units/wk; P=0.04). Overall, 90.3% of subjects on FC and 89.3% of subjects on AC experienced adverse events. In conclusion, treatment with FC as a phosphate binder results in increased iron parameters apparent after 12 weeks and reduces iv iron and ESA use while maintaining hemoglobin over 52 weeks, with a safety profile similar to that of available binders.

KEYWORDS:

ESA; ESRD; anemia; dialysis; erythropoietin; ferric citrate; iron; phosphate binder

PMID:
25736045
PMCID:
PMC4587699
DOI:
10.1681/ASN.2014080842
[Indexed for MEDLINE]
Free PMC Article

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