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Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia.
J Am Soc Nephrol. 2017 Jun; 28(6):1851-1858.JA

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28082519

Citation

Fishbane, Steven, et al. "Effects of Ferric Citrate in Patients With Nondialysis-Dependent CKD and Iron Deficiency Anemia." Journal of the American Society of Nephrology : JASN, vol. 28, no. 6, 2017, pp. 1851-1858.
Fishbane S, Block GA, Loram L, et al. Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia. J Am Soc Nephrol. 2017;28(6):1851-1858.
Fishbane, S., Block, G. A., Loram, L., Neylan, J., Pergola, P. E., Uhlig, K., & Chertow, G. M. (2017). Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia. Journal of the American Society of Nephrology : JASN, 28(6), 1851-1858. https://doi.org/10.1681/ASN.2016101053
Fishbane S, et al. Effects of Ferric Citrate in Patients With Nondialysis-Dependent CKD and Iron Deficiency Anemia. J Am Soc Nephrol. 2017;28(6):1851-1858. PubMed PMID: 28082519.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia. AU - Fishbane,Steven, AU - Block,Geoffrey A, AU - Loram,Lisa, AU - Neylan,John, AU - Pergola,Pablo E, AU - Uhlig,Katrin, AU - Chertow,Glenn M, Y1 - 2017/01/12/ PY - 2016/10/01/received PY - 2016/11/23/accepted PY - 2017/1/14/pubmed PY - 2017/6/29/medline PY - 2017/1/14/entrez KW - anemia KW - blood transfusion KW - clinical trial KW - hemoglobin KW - iron deficiency KW - renal dialysis SP - 1851 EP - 1858 JF - Journal of the American Society of Nephrology : JASN JO - J Am Soc Nephrol VL - 28 IS - 6 N2 - 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. SN - 1533-3450 UR - https://www.unboundmedicine.com/medline/citation/28082519/Effects_of_Ferric_Citrate_in_Patients_with_Nondialysis_Dependent_CKD_and_Iron_Deficiency_Anemia_ L2 - https://jasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=28082519 DB - PRIME DP - Unbound Medicine ER -