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Original ArticlesChronic Kidney Disease
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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

Rebecca Womack, Fabian Berru, Bhupesh Panwar and Orlando M. Gutiérrez
CJASN September 2020, 15 (9) 1251-1258; DOI: https://doi.org/10.2215/CJN.15291219
Rebecca Womack
1Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
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Fabian Berru
1Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
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Bhupesh Panwar
1Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
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Orlando M. Gutiérrez
1Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama
2Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama
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    Figure 1.

    Study flow diagram.

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    Figure 2.

    Percent transferrin saturation and ferritin concentrations increased in those randomized to ferric citrate but not those randomized to ferrous sulfate over 12 weeks. Transferrin saturation (TSAT) (A) and ferritin (B). Results shown as mean±SD. Asterisks denote statistically significant difference from the baseline value. The P values for the group×time interaction terms for TSAT and ferritin were 0.14 and <0.001, respectively.

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    Table 1.

    Baseline characteristics of the study sample by randomization arm

    CharacteristicFerric CitrateFerrous Sulfate
    N3030
    Age, yr60±1263±11
    Men, n (%)10 (33)11 (37)
    Black race, n (%)16 (53)17 (57)
    Body mass index, kg/m237±836±9
    Systolic BP, mm Hg136±21134±20
    Diastolic BP, mm Hg74±1173±10
    Comorbidities, n (%)
     Diabetes16 (57)18 (62)
     Hypertension30 (100)28 (93)
     Coronary artery disease4 (15)3 (10)
     Heart failure3 (11)6 (21)
     Stroke3 (10)3 (10)
     Dyslipidemia15 (54)19 (65)
     COPD2 (6)2 (6)
    Attributed cause of CKD, n (%)
     Diabetes15 (50)17 (57)
     Hypertension5 (17)4 (13)
     GN2 (7)1 (3)
     PKD2 (7)3 (10)
     Other4 (13)3 (10)
     Unknown2 (7)2 (7)
    Medication use, n (%)
     Aspirin10 (33)19 (63)
     Statin17 (57)22 (73)
     β-Blocker20 (67)19 (63)
     ACE inhibitor10 (33)7 (23)
     ARB12 (40)10 (34)
     Oral iron7 (23)6 (20)
    Laboratory values
     Phosphate, mg/dl3.7±0.53.9±0.8
     Calcium, mg/dl9.3±0.49.3±0.7
     eGFR, ml/min per 1.73 m233±1226±14
     TSAT, %18±619±6
     Ferritin, ng/ml90±70100±59
     Hemoglobin, g/dl11.4±1.011.0±1.0
     iFGF23, pg/ml92 [65–120]160 [97–241]
     cFGF23, RU/ml179 [130–242]278 [181–526]
     PTH, pg/ml136±80153±93
    • Values are depicted as proportions (n, %), mean (SD), or median [interquartile range]. COPD, chronic obstructive pulmonary disease; PKD, polycystic kidney disease; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; TSAT, transferrin saturation; iFGF23, intact fibroblast growth factor 23; cFGF23, C-terminal fibroblast growth factor 23; PTH, parathyroid hormone.

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    Table 2.

    Changes in iron parameters, hemoglobin, fibroblast growth factor 23, and hepcidin after 12 weeks of ferric citrate versus ferrous sulfate

    Baseline Values, Mean (SD)12-Wk Change from Baseline, Mean Estimate (95% CI)
    VariableFerrous SulfateFerric CitrateFerrous SulfateFerric CitrateDifferenceP Value
    Primary outcomes
     TSAT, %21 (7)19 (7)−1 (−3 to 2)8 (1 to 14)8 (1 to 15)0.02
     Ferritin, ng/ml104 (63)87 (61)12 (−4 to 28)49 (26 to 73)37 (10 to 64)0.009
    Secondary outcomes
     Hemoglobin, g/dl11.0 (1.1)11.4 (1.1)0.0 (−0.3 to 0.4)0.3 (0.1 to 0.5)0.3 (−0.1 to 0.2)0.19
     iFGF23, pg/ml178 (102)160 (290)−7 (−22 to 8)−37 (−74 to 0)−29 (−59 to 0.1)0.05
     cFGF23, RU/ml437 (510)291 (353)−104 (−219 to 11)−45 (−92 to 1)61 (−58 to 181)0.31
     Hepcidin, pg/ml87 (48)82 (61)21 (−8 to 49)90 (30 to 150)69 (8 to 130)0.03
    • 95% CI, 95% confidence interval; TSAT, transferrin saturation; iFGF23, intact fibroblast growth factor 23; cFGF23, C-terminal fibroblast growth factor 23.

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    Table 3.

    Number (proportion) of adverse events by randomization arm (reported in 10% or more in either group)

    Adverse EventFerric Citrate, n (%)Ferrous Sulfate, n (%)
    Total N3030
    Weight loss3 (10)7 (24)
    Weight gain5 (17)8 (27)
    Fatigue6 (20)3 (10)
    Infection5 (17)1 (4)
    Eye pain2 (7)5 (17)
    Vision changes4 (14)1 (4)
    Nasal congestion3 (10)4 (14)
    Shortness of breath2 (7)5 (16)
    Cough3 (10)1 (4)
    Nausea6 (20)5 (16)
    Diarrhea9 (30)5 (16)
    Constipation9 (30)11 (36)
    Change in stool color16 (53)8 (27)
    Anorexia2 (7)8 (27)
    GERD3 (10)1 (4)
    Frequency2 (7)5 (16)
    Muscle pain3 (10)2 (7)
    Edema04 (14)
    Headache2 (7)6 (20)
    Change smell/taste3 (10)2 (7)
    • GERD, gastroesophageal reflux disease.

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Clinical Journal of the American Society of Nephrology: 15 (9)
Clinical Journal of the American Society of Nephrology
Vol. 15, Issue 9
September 07, 2020
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Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD
Rebecca Womack, Fabian Berru, Bhupesh Panwar, Orlando M. Gutiérrez
CJASN Sep 2020, 15 (9) 1251-1258; DOI: 10.2215/CJN.15291219

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Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD
Rebecca Womack, Fabian Berru, Bhupesh Panwar, Orlando M. Gutiérrez
CJASN Sep 2020, 15 (9) 1251-1258; DOI: 10.2215/CJN.15291219
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Keywords

  • chronic renal disease
  • clinical trial
  • mineral metabolism
  • anemia
  • ferrous sulfate
  • ferric citrate
  • Iron Deficiency

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