Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study

Abstract

A 56-day treatment with ferric citrate effectively controlled hyperphosphatemia and was well tolerated in maintenance hemodialysis patients. There were also moderate increases in serum ferritin and transferrin saturation.

Ferric Citrate

“…However, at week 8, the bicarbonate level was 23.75 mmol/L in the ferric citrate 6 g/day group compared with 21.8 mmol/L in the placebo group (P = .028). 7 In a phase 2 trial providing ferric citrate 4.5 to 11.25 g/day for 4 weeks, an increase in bicarbonate from 22.2 mEq/L at baseline to 23.7 mEq/L at end of study was noted. 29 Ferric citrate is classified as Pregnancy Category B; no adequate and well-controlled studies in pregnant women have been conducted.…”

“…6 Potential complications as a result of these events include the development of CKD-associated mineral and bone disorders (CKD-MBD), extraskeletal calcification of soft tissue, and increased risk of mortality. 3,5,[6][7][8] In addition to dietary phosphate restriction and dialysis, current therapies to lower serum phosphate act by binding phosphate in the gut prior to absorption. 3,5 Such products include aluminum hydroxide, calcium-based binders, lanthanum and sevelamer products, and iron-based phosphate binders.…”

“…20,[25][26][27] A phase 3 study of ferric citrate in Taiwan noted increases in ferritin with 4 and 6 g/day of ferric citrate from baseline to week 8 compared with placebo. 7 Assessment of iron parameters (eg, serum ferritin, TSAT) should occur prior to the start of the ferric citrate and be monitored throughout therapy. 1 Ferric citrate is an iron-containing product and should be kept out of reach of children.…”

“…33 In a phase 3 trial of ferric citrate conducted in Taiwan, discoloration of stool was reported in 2 of 36 patients given placebo compared with 28 of 75 patients given ferric citrate 4 g/day and 27 of 72 patients given ferric citrate 6 g/day. 7 Cautious use may be warranted in patients with a history or current GI disorders. In ferric citrate studies, patients with GI abnormality, active GI bleeding, inflammatory bowel disease, or diabetes mellitus with clinically relevant gastroparesis were excluded from participation.…”

“…1 Animal studies found some transfer of iron into milk; it may be possible for breast-feeding infants to be exposed to ferric citrate. 1,5,7,29,33,37 A phase 3 study administering ferric citrate 1, 6, and 8 g/day for 4 weeks noted the lower rate of adverse events in the 1 g/day cohort and similar rate in the 6 and 8 g/day cohorts. The rate of drug-related adverse events, serious adverse events, or events leading to discontinuation increased with the dose.…”