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Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial.
Clin J Am Soc Nephrol. 2020 09 07; 15(9):1251-1258.CJ

Abstract

BACKGROUND AND OBJECTIVES

Ferric citrate is an oral medication approved for treatment of iron deficiency anemia in patients with CKD not requiring dialysis. The relative efficacy of ferric citrate versus ferrous sulfate in treating iron deficiency in patients with CKD is unclear.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS

We randomized 60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m2) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to ferric citrate (2 g three times a day with meals, n=30) or ferrous sulfate (325 mg three times a day, n=30) for 12 weeks. Primary outcomes were change in TSAT and ferritin from baseline to 12 weeks. Secondary outcomes were change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin.

RESULTS

Baseline characteristics were well balanced between study arms. There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15; P=0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64; P=0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate. Similarly, as compared with ferrous sulfate, treatment with ferric citrate resulted in a greater increase in hepcidin from baseline to 12 weeks (between-group difference, 69 pg/ml; 95% CI, 8 to 130). There were no between-group differences in mean change for hemoglobin (0.3 g/dl; 95% CI, -0.2 to 0.8), intact FGF23 (-29 pg/ml; 95% CI, -59 to 0.1), or C-terminal FGF23 (61 RU/ml; 95% CI, -181 to 58). The incidence of adverse events did not differ between treatment arms.

CONCLUSIONS

As compared with ferrous sulfate, treatment with ferric citrate for 12 weeks resulted in a greater mean increase in TSAT and ferritin concentrations in individuals with moderate to severe CKD and iron deficiency.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With Moderate to Severe Chronic Kidney Disease (CKD) With Iron Deficiency, NCT02888171.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama ogutierrez@uabmc.edu. Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

32694162

Citation

Womack, Rebecca, et al. "Effect of Ferric Citrate Versus Ferrous Sulfate On Iron and Phosphate Parameters in Patients With Iron Deficiency and CKD: a Randomized Trial." Clinical Journal of the American Society of Nephrology : CJASN, vol. 15, no. 9, 2020, pp. 1251-1258.
Womack R, Berru F, Panwar B, et al. Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. Clin J Am Soc Nephrol. 2020;15(9):1251-1258.
Womack, R., Berru, F., Panwar, B., & Gutiérrez, O. M. (2020). Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. Clinical Journal of the American Society of Nephrology : CJASN, 15(9), 1251-1258. https://doi.org/10.2215/CJN.15291219
Womack R, et al. Effect of Ferric Citrate Versus Ferrous Sulfate On Iron and Phosphate Parameters in Patients With Iron Deficiency and CKD: a Randomized Trial. Clin J Am Soc Nephrol. 2020 09 7;15(9):1251-1258. PubMed PMID: 32694162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. AU - Womack,Rebecca, AU - Berru,Fabian, AU - Panwar,Bhupesh, AU - Gutiérrez,Orlando M, Y1 - 2020/07/21/ PY - 2019/12/14/received PY - 2020/06/22/accepted PY - 2020/7/23/pubmed PY - 2021/12/15/medline PY - 2020/7/23/entrez KW - Iron Deficiency KW - anemia KW - chronic renal disease KW - clinical trial KW - ferric citrate KW - ferrous sulfate KW - mineral metabolism SP - 1251 EP - 1258 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 15 IS - 9 N2 - BACKGROUND AND OBJECTIVES: Ferric citrate is an oral medication approved for treatment of iron deficiency anemia in patients with CKD not requiring dialysis. The relative efficacy of ferric citrate versus ferrous sulfate in treating iron deficiency in patients with CKD is unclear. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We randomized 60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m2) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to ferric citrate (2 g three times a day with meals, n=30) or ferrous sulfate (325 mg three times a day, n=30) for 12 weeks. Primary outcomes were change in TSAT and ferritin from baseline to 12 weeks. Secondary outcomes were change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin. RESULTS: Baseline characteristics were well balanced between study arms. There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15; P=0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64; P=0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate. Similarly, as compared with ferrous sulfate, treatment with ferric citrate resulted in a greater increase in hepcidin from baseline to 12 weeks (between-group difference, 69 pg/ml; 95% CI, 8 to 130). There were no between-group differences in mean change for hemoglobin (0.3 g/dl; 95% CI, -0.2 to 0.8), intact FGF23 (-29 pg/ml; 95% CI, -59 to 0.1), or C-terminal FGF23 (61 RU/ml; 95% CI, -181 to 58). The incidence of adverse events did not differ between treatment arms. CONCLUSIONS: As compared with ferrous sulfate, treatment with ferric citrate for 12 weeks resulted in a greater mean increase in TSAT and ferritin concentrations in individuals with moderate to severe CKD and iron deficiency. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With Moderate to Severe Chronic Kidney Disease (CKD) With Iron Deficiency, NCT02888171. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/32694162/Effect_of_Ferric_Citrate_versus_Ferrous_Sulfate_on_Iron_and_Phosphate_Parameters_in_Patients_with_Iron_Deficiency_and_CKD:_A_Randomized_Trial_ L2 - https://cjasn.asnjournals.org/cgi/pmidlookup?view=long&pmid=32694162 DB - PRIME DP - Unbound Medicine ER -