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A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5.
Am J Kidney Dis. 2015 May; 65(5):728-36.AJ

Abstract

BACKGROUND

Iron deficiency anemia and serum phosphate levels > 4.0mg/dL are relatively common in chronic kidney disease stages 3 to 5 and are associated with higher risks of progressive loss of kidney function, cardiovascular events, and mortality.

STUDY DESIGN

Double-blind, placebo-controlled, randomized trial.

SETTING & PARTICIPANTS

149 patients with estimated glomerular filtration rates < 60 mL/min/1.73 m(2), iron deficiency anemia (hemoglobin, 9.0-12.0 g/dL; transferrin saturation [TSAT]≤ 30%, serum ferritin ≤ 300 ng/mL), and serum phosphate levels ≥ 4.0 to 6.0mg/dL. Use of intravenous iron or erythropoiesis-stimulating agents was prohibited.

INTERVENTION

Randomization to treatment for 12 weeks with ferric citrate coordination complex (ferric citrate) or placebo.

OUTCOMES & MEASUREMENTS

Coprimary end points were change in TSAT and serum phosphate level from baseline to end of study. Secondary outcomes included change from baseline to end of treatment in values for ferritin, hemoglobin, intact fibroblast growth factor 23 (FGF-23), urinary phosphate excretion, and estimated glomerular filtration rate.

RESULTS

Ferric citrate treatment increased mean TSAT from 22% ± 7% (SD) to 32% ± 14% and reduced serum phosphate levels from 4.5 ± 0.6 to 3.9 ± 0.6 mg/dL, while placebo exerted no effect on TSAT (21% ± 8% to 20% ± 8%) and less effect on serum phosphate level (4.7 ± 0.6 to 4.4 ± 0.8 mg/dL; between-group P<0.001 for each). Ferric citrate increased hemoglobin levels (from 10.5 ± 0.8 to 11.0 ± 1.0 g/dL; P<0.001 vs placebo), reduced urinary phosphate excretion 39% (P<0.001 vs placebo), and reduced serum intact FGF-23 levels from a median of 159 (IQR, 102-289) to 105 (IQR, 65-187) pg/mL (P=0.02 vs placebo). The incidence and severity of adverse effects were similar between treatment arms.

LIMITATIONS

The study is limited by relatively small sample size and short duration and by having biochemical rather than clinical outcomes.

CONCLUSIONS

Short-term use of ferric citrate repletes iron stores, increases hemoglobin levels, and reduces levels of serum phosphate, urinary phosphate excretion, and FGF-23 in patients with chronic kidney disease stages 3 to 5.

Authors+Show Affiliations

Denver Nephrologists PC, Denver, CO. Electronic address: gablock@dnresearch.org.Hofstra-North Shore LIJ School of Medicine, Great Neck, NY.Nephrology Service, IMIBIC, Hospital Universitario, Cordoba, Spain.Denver Nephrologists PC, Denver, CO.Keryx Biopharmaceuticals Inc, New York, NY.Renal Associates PA, San Antonio, TX.Department of Medicine, Institute for Public Health and Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL.Stanford University School of Medicine, Palo Alto, CA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25468387

Citation

Block, Geoffrey A., et al. "A 12-week, Double-blind, Placebo-controlled Trial of Ferric Citrate for the Treatment of Iron Deficiency Anemia and Reduction of Serum Phosphate in Patients With CKD Stages 3-5." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 65, no. 5, 2015, pp. 728-36.
Block GA, Fishbane S, Rodriguez M, et al. A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. Am J Kidney Dis. 2015;65(5):728-36.
Block, G. A., Fishbane, S., Rodriguez, M., Smits, G., Shemesh, S., Pergola, P. E., Wolf, M., & Chertow, G. M. (2015). A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 65(5), 728-36. https://doi.org/10.1053/j.ajkd.2014.10.014
Block GA, et al. A 12-week, Double-blind, Placebo-controlled Trial of Ferric Citrate for the Treatment of Iron Deficiency Anemia and Reduction of Serum Phosphate in Patients With CKD Stages 3-5. Am J Kidney Dis. 2015;65(5):728-36. PubMed PMID: 25468387.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. AU - Block,Geoffrey A, AU - Fishbane,Steven, AU - Rodriguez,Mariano, AU - Smits,Gerard, AU - Shemesh,Shay, AU - Pergola,Pablo E, AU - Wolf,Myles, AU - Chertow,Glenn M, Y1 - 2014/11/04/ PY - 2014/05/27/received PY - 2014/10/05/accepted PY - 2014/12/4/entrez PY - 2014/12/4/pubmed PY - 2015/7/24/medline KW - Chronic kidney disease (CKD) KW - ferric citrate coordination complex (ferric citrate) KW - fibroblast growth factor 23 (FGF-23) KW - hemoglobin KW - iron repletion KW - iron-deficiency anemia KW - oral iron therapy KW - phosphate binder KW - randomized controlled trial KW - serum phosphate KW - transferrin saturation (TSAT) KW - urinary phosphate excretion SP - 728 EP - 36 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 65 IS - 5 N2 - BACKGROUND: Iron deficiency anemia and serum phosphate levels > 4.0mg/dL are relatively common in chronic kidney disease stages 3 to 5 and are associated with higher risks of progressive loss of kidney function, cardiovascular events, and mortality. STUDY DESIGN: Double-blind, placebo-controlled, randomized trial. SETTING & PARTICIPANTS: 149 patients with estimated glomerular filtration rates < 60 mL/min/1.73 m(2), iron deficiency anemia (hemoglobin, 9.0-12.0 g/dL; transferrin saturation [TSAT]≤ 30%, serum ferritin ≤ 300 ng/mL), and serum phosphate levels ≥ 4.0 to 6.0mg/dL. Use of intravenous iron or erythropoiesis-stimulating agents was prohibited. INTERVENTION: Randomization to treatment for 12 weeks with ferric citrate coordination complex (ferric citrate) or placebo. OUTCOMES & MEASUREMENTS: Coprimary end points were change in TSAT and serum phosphate level from baseline to end of study. Secondary outcomes included change from baseline to end of treatment in values for ferritin, hemoglobin, intact fibroblast growth factor 23 (FGF-23), urinary phosphate excretion, and estimated glomerular filtration rate. RESULTS: Ferric citrate treatment increased mean TSAT from 22% ± 7% (SD) to 32% ± 14% and reduced serum phosphate levels from 4.5 ± 0.6 to 3.9 ± 0.6 mg/dL, while placebo exerted no effect on TSAT (21% ± 8% to 20% ± 8%) and less effect on serum phosphate level (4.7 ± 0.6 to 4.4 ± 0.8 mg/dL; between-group P<0.001 for each). Ferric citrate increased hemoglobin levels (from 10.5 ± 0.8 to 11.0 ± 1.0 g/dL; P<0.001 vs placebo), reduced urinary phosphate excretion 39% (P<0.001 vs placebo), and reduced serum intact FGF-23 levels from a median of 159 (IQR, 102-289) to 105 (IQR, 65-187) pg/mL (P=0.02 vs placebo). The incidence and severity of adverse effects were similar between treatment arms. LIMITATIONS: The study is limited by relatively small sample size and short duration and by having biochemical rather than clinical outcomes. CONCLUSIONS: Short-term use of ferric citrate repletes iron stores, increases hemoglobin levels, and reduces levels of serum phosphate, urinary phosphate excretion, and FGF-23 in patients with chronic kidney disease stages 3 to 5. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/25468387/A_12_week_double_blind_placebo_controlled_trial_of_ferric_citrate_for_the_treatment_of_iron_deficiency_anemia_and_reduction_of_serum_phosphate_in_patients_with_CKD_Stages_3_5_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(14)01357-2 DB - PRIME DP - Unbound Medicine ER -