The safety and tolerability of ferric citrate as a phosphate binder in dialysis patients.

Sinsakul M, Sika M, Koury M, Shapiro W, Greene T, Dwyer J, Smith M, Korbet S, Lewis J, Collaborative Study Group
Nephron Clin Pract. 2012 121 (1-2): c25-9

PMID: 23075669 · DOI:10.1159/000341922

BACKGROUND - A phase II open-label study was conducted in hemodialysis patients evaluating the short-term safety, tolerability, and iron absorption with ferric citrate when used as a phosphate binder.

METHODS - Enrollment occurred in two periods. Period 1 recruited patients taking 6-15 pills/day of binder with phosphorus of ≥2.5 mg/dl. Period 2 recruited patients taking ≥12 pills/day of binder with phosphorus of ≥3.5 mg/dl. Participants with ferritin ≥1,000 µg/l or transferrin iron saturation (TSAT) ≥50% at screening were excluded. Subjects discontinued their previous binders and started 4.5 g/day of ferric citrate (period 1) or 6 g/day (period 2) and were titrated for 4 weeks to maintain a phosphorus of 3.5-5.5 mg/dl. Chemistries and complete blood count were obtained weekly and a gastrointestinal questionnaire was administered at drug initiation and final visit. Iron therapy was permitted if the ferritin was <500 µg/l and TSAT <30%.

RESULTS - Fifty-five subjects were enrolled. Four serious adverse events were reported; none were related to the study drug. Findings from the gastrointestinal questionnaire included stool discoloration (69%), constipation (15%), and bloating (7%). Mean iron parameters at the beginning of the study were ferritin 554 ± 296 µg/l, iron 68 ± 21 µg/dl, and iron saturation 30 ± 7.8%. At the end of study, mean ferritin was 609 ± 340 µg/l (p = 0.02), iron 75 ± 27 µg/dl (p = 0.04), and TSAT was 35 ± 13% (p = 0.001). Mean phosphorus and calcium levels were unchanged from baseline at the end of study.

CONCLUSION - Ferric citrate was well tolerated by patients after 4 weeks with no significant clinical or biochemical adverse events related to exposure.

Copyright © 2012 S. Karger AG, Basel.

MeSH Terms (17)

Adult Chelating Agents Chronic Kidney Disease-Mineral and Bone Disorder Color Constipation Feces Female Ferric Compounds Ferritins Humans Iron Kidney Failure, Chronic Male Middle Aged Phosphorus Renal Dialysis Surveys and Questionnaires

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