Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study.
BACKGROUND
Hyperphosphatemia is a common complication in dialysis patients that can be treated by oral phosphate binders. We investigated the efficacy and safety of oral ferric citrate as a phosphate binder for Taiwanese patients with end stage renal disease and with hyperphosphatemia who were undergoing hemodialysis.


METHODS
This was a prospective, double-blind, placebo-controlled, randomized trial carried out in 5 hospitals in Taiwan. Ferric citrate (4 or 6 g/day) or placebo was administered for 56 days. Serum calcium, phosphorous levels, calcium × phosphorus product, serum ferritin level, transferrin saturation, and adverse events were recorded.


RESULTS
A total of 166 patients completed the trial. The placebo group had relatively constant serum data. Serum phosphorus declined significantly in the 6 g/day group (p < 0.05 for 4 and 8 weeks) and the 4 g/day group (p < 0.05 for 4 and 8 weeks). There were similar changes in the calcium × phosphorus product. The serum ferritin level increased significantly in the 6 g/day group (p < 0.05) and the 4 g/day group (p < 0.05). There were similar changes in transferrin saturation. Most adverse events were mild to moderate and were comparable among the three groups.


CONCLUSIONS
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.
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, Taiwan.
Chien-Te
CT
Lee
I-Wen
IW
Wu
Shou-Shan
SS
Chiang
Yu-Sen
YS
Peng
Kuo-Hsiung
KH
Shu
Ming-Ju
MJ
Wu
Mai-Szu
MS
Wu
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002614:Chelating Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005293:Ferritins / Q000097:blood; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood*; D006435:Renal Dialysis / Q000009:adverse effects; D014168:Transferrin / Q000378:metabolism
D002614:Chelating Agents; D005290:Ferric Compounds; D014168:Transferrin; D010758:Phosphorus; C025314:ferric citrate; D005293:Ferritins