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J Am Soc Nephrol. 2017 Jun;28(6):1851-1858. doi: 10.1681/ASN.2016101053. Epub 2017 Jan 12.

Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia.

Author information

1
Division of Nephrology, Department of Medicine, Hofstra Northwell School of Medicine, Mineola, New York.
2
Denver Nephrology, Denver, Colorado.
3
Keryx Biopharmaceuticals Inc., Boston, Massachusetts.
4
Renal Associates Professional Association, San Antonio, Texas; and.
5
Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California gchertow@stanford.edu.

Abstract

Iron deficiency anemia is common and consequential in nondialysis-dependent CKD (NDD-CKD). Efficacy and tolerability of conventional oral iron supplements are mixed; intravenous iron administration associates with finite but important risks. We conducted a randomized double-blind clinical trial in adults with NDD-CKD and iron deficiency anemia to compare the safety and efficacy of oral ferric citrate (n=117) and placebo (n=115). The primary end point was the proportion of patients who achieved a ≥1.0 g/dl increase in hemoglobin at any time during a 16-week randomized period. Patients who completed the 16-week period could also participate in an 8-week open-label extension period. Significantly more patients randomized to ferric citrate achieved the primary end point (61 [52.1%] versus 22 [19.1%] with placebo; P<0.001). All secondary end points reached statistical significance in the ferric citrate group, including the mean relative change in hemoglobin (0.84 g/dl; 95% confidence interval, 0.58 to 1.10 g/dl; P<0.001) and the proportion of patients who achieved a sustained increase in hemoglobin (≥0.75 g/dl over any 4-week period during the randomized trial; 57 [48.7%] versus 17 [14.8%] with placebo; P<0.001). Rates of serious adverse events were similar in the ferric citrate (12.0%) and placebo groups (11.2%). Gastrointestinal disorders were the most common adverse events, with diarrhea reported in 24 (20.5%) and 19 (16.4%) and constipation in 22 (18.8%) and 15 (12.9%) patients treated with ferric citrate and placebo, respectively. Overall, in patients with NDD-CKD, we found oral ferric citrate to be a safe and efficacious treatment for iron deficiency anemia.

KEYWORDS:

anemia; blood transfusion; clinical trial; hemoglobin; iron deficiency; renal dialysis

PMID:
28082519
PMCID:
PMC5461803
DOI:
10.1681/ASN.2016101053
[Indexed for MEDLINE]
Free PMC Article

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