Abstract | BACKGROUND: STUDY DESIGN: Double-blind, placebo-controlled, randomized trial. SETTING & PARTICIPANTS: INTERVENTION: 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:
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Authors | Geoffrey A Block, Steven Fishbane, Mariano Rodriguez, Gerard Smits, Shay Shemesh, Pablo E Pergola, Myles Wolf, Glenn M Chertow |
Journal | American journal of kidney diseases : the official journal of the National Kidney Foundation
(Am J Kidney Dis)
Vol. 65
Issue 5
Pg. 728-36
(May 2015)
ISSN: 1523-6838 [Electronic] United States |
PMID | 25468387
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- FGF23 protein, human
- Ferric Compounds
- Hematinics
- Phosphates
- Fibroblast Growth Factors
- ferric citrate
- Fibroblast Growth Factor-23
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Topics |
- Aged
- Anemia, Iron-Deficiency
(drug therapy)
- Disease Progression
- Double-Blind Method
- Female
- Ferric Compounds
(therapeutic use)
- Fibroblast Growth Factor-23
- Fibroblast Growth Factors
(blood)
- Hematinics
(therapeutic use)
- Humans
- Male
- Middle Aged
- Phosphates
(blood, urine)
- Renal Insufficiency, Chronic
(blood)
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