Table 1.
Randomized controlled trials of ferric citrate in adult patients with non-dialysis-dependent CKD. FC, ferric citrate; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; TSAT, transferrin saturation; FGF23, fibroblast growth factor 23; LS, least squares
| Study | Study details | Study parameters | Effects of ferric citrate | p-value for between-group differences |
|---|---|---|---|---|
| Yokoyama et al. [53] |
FC (n = 57) vs. placebo (n = 29) 12-week duration Inclusive of CKD stages 3–5 (mean eGFR 9 ml/min/1.73 m2) Mean age 65 years |
Phosphate TSAT Ferritin Hemoglobin FGF23 |
Decreased from mean 5.7 to 4.4 mg/dl Increased from mean 27 to 44% Increased from mean 69 to 204 ng/ml Increased from mean 10.3 to 10.7 g/dl Decreased from median 453 to 209 pg/ml |
< 0.001 < 0.001 < 0.001 0.23 < 0.001 |
| Block et al. [54] |
FC (n = 72) vs. placebo (n = 69) 12-week duration Inclusive of CKD stages 3–5 (mean eGFR 24 ml/min/1.73 m2) Mean age 65 years |
Phosphate TSAT Ferritin Hemoglobin FGF23 |
Decreased from mean 4.5 to 3.9 mg/dl Increased from mean 22 to 32% Increased from mean 116 to 189 ng/ml Increased from mean 10.5 to 11.0 g/dl Decreased from median 159 to 105 pg/ml |
< 0.001 < 0.001 < 0.001 < 0.001 0.02 |
| Fishbane et al. [55] |
FC (n = 117) vs. placebo (n = 116) 16-week duration Inclusive of CKD stages 3–5 (mean eGFR 29 ml/min/1.73 m2) Mean age 65 years |
Phosphate TSAT Ferritin Hemoglobin FGF23 |
Mean relative change vs. placebo of − 0.2 mg/dl Mean relative change vs. placebo of + 18% Mean relative change vs. placebo of + 170 ng/ml Mean relative change vs. placebo of + 0.8 g/dl Decreased from median 134 to 105 pg/ml |
0.02 < 0.001 < 0.001 < 0.001 < 0.001 |
| Block et al. [56] |
FC (n = 133) vs. usual care (n = 66) 36-week duration Inclusive of eGFR < 20 ml/min/1.73 m2 (mean eGFR 14 ml/min/1.73 m2) Mean age 62 years |
Phosphate TSAT Ferritin Hemoglobin FGF23 |
Lower LS mean vs. usual care (4.2 vs. 4.6 mg/dl) Increased with FC, unchanged with usual care Increased with FC, unchanged with usual care Increased with FC, decreased with usual care Unchanged with FC, increased with usual care |
< 0.001 < 0.001 < 0.001 < 0.001 < 0.001 |