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The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial.
Am J Kidney Dis. 2015 Sep; 66(3):479-88.AJ

Abstract

BACKGROUND

Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels.

STUDY DESIGN

52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment.

SETTING & PARTICIPANTS

Maintenance dialysis patients with serum phosphorus levels ≥6.0 mg/dL after washout of prior phosphate binders.

INTERVENTION

2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate).

OUTCOMES

Changes in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year.

MEASUREMENTS

Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate.

RESULTS

There were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (-2.04±1.99 [SD] vs -2.18±2.25 mg/dL, respectively; P=0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22±0.90 vs 0.31±0.95 mg/dL; P=0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (-167.1±399.8 vs -152.7±392.1 pg/mL; P=0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control.

LIMITATIONS

Open-label study, few peritoneal dialysis patients.

CONCLUSIONS

Ferric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate.

Authors+Show Affiliations

University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: peter.vanburen@utsouthwestern.edu.Vanderbilt University Medical Center, Nashville, TN.Vanderbilt University Medical Center, Nashville, TN.University of Utah Medical Center, Salt Lake City, UT.Duke University Medical Center, Durham, NC.Vanderbilt University Medical Center, Nashville, TN.Henry Ford Medical Center, Detroit, MI.University of Utah Medical Center, Salt Lake City, UT.Nephrology Specialists PC, Michigan City, IN.Wake Forest University Medical Center, Winston-Salem, NC.Ichilov Medical Center, Tel Aviv, Israel.Kidney Associates PLLC, Houston, TX.University of Pennsylvania Medical Center, Philadelphia, PA.Vanderbilt University Medical Center, Nashville, TN.Rush University Medical Center, Chicago, IL.Tufts Medical Center, Boston, MA.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

25958079

Citation

Van Buren, Peter N., et al. "The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 66, no. 3, 2015, pp. 479-88.
Van Buren PN, Lewis JB, Dwyer JP, et al. The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial. Am J Kidney Dis. 2015;66(3):479-88.
Van Buren, P. N., Lewis, J. B., Dwyer, J. P., Greene, T., Middleton, J., Sika, M., Umanath, K., Abraham, J. D., Arfeen, S. S., Bowline, I. G., Chernin, G., Fadem, S. Z., Goral, S., Koury, M., Sinsakul, M. V., & Weiner, D. E. (2015). The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 66(3), 479-88. https://doi.org/10.1053/j.ajkd.2015.03.013
Van Buren PN, et al. The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial. Am J Kidney Dis. 2015;66(3):479-88. PubMed PMID: 25958079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial. AU - Van Buren,Peter N, AU - Lewis,Julia B, AU - Dwyer,Jamie P, AU - Greene,Tom, AU - Middleton,John, AU - Sika,Mohammed, AU - Umanath,Kausik, AU - Abraham,Josephine D, AU - Arfeen,Shahabul S, AU - Bowline,Isai G, AU - Chernin,Gil, AU - Fadem,Stephen Z, AU - Goral,Simin, AU - Koury,Mark, AU - Sinsakul,Marvin V, AU - Weiner,Daniel E, AU - ,, Y1 - 2015/05/07/ PY - 2014/11/04/received PY - 2015/03/03/accepted PY - 2015/5/11/entrez PY - 2015/5/11/pubmed PY - 2015/11/18/medline KW - Hemodialysis KW - adverse events KW - calcium acetate KW - end-stage renal disease (ESRD) KW - ferric citrate KW - hyperphosphatemia KW - mineral bone disease KW - phosphate binder KW - protein-energy wasting (PEW)/inflammation KW - safety KW - sevelamer carbonate SP - 479 EP - 88 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 66 IS - 3 N2 - BACKGROUND: Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels. STUDY DESIGN: 52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment. SETTING & PARTICIPANTS: Maintenance dialysis patients with serum phosphorus levels ≥6.0 mg/dL after washout of prior phosphate binders. INTERVENTION: 2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate). OUTCOMES: Changes in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year. MEASUREMENTS: Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate. RESULTS: There were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (-2.04±1.99 [SD] vs -2.18±2.25 mg/dL, respectively; P=0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22±0.90 vs 0.31±0.95 mg/dL; P=0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (-167.1±399.8 vs -152.7±392.1 pg/mL; P=0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control. LIMITATIONS: Open-label study, few peritoneal dialysis patients. CONCLUSIONS: Ferric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/25958079/The_Phosphate_Binder_Ferric_Citrate_and_Mineral_Metabolism_and_Inflammatory_Markers_in_Maintenance_Dialysis_Patients:_Results_From_Prespecified_Analyses_of_a_Randomized_Clinical_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(15)00541-7 DB - PRIME DP - Unbound Medicine ER -