Table 1.
Baseline demographics and disease characteristics (intention-to-treat population)
| Characteristics | Ferric citrate | Placebo |
|---|---|---|
| (n = 117) | (n = 115) | |
| Age (years) | 65.6 (11.2) | 65.3 (13.0) |
| Male gender, n (%) | 41 (35.0) | 44 (38.3) |
| Race, n (%) | ||
| White | 78 (66.7) | 81 (70.4) |
| Black or African American | 38 (32.5) | 31 (27.0) |
| Other | 1 (0.9) | 3 (2.6) |
| Hispanic or Latino ethnicity, n (%) | 29 (24.8) | 23 (20.0) |
| Body mass index (kg/m2) | 34.4 (8.2) | 33.5 (8.2)a |
| Patients with diabetes, n (%) | 85 (72.6) | 81 (70.4) |
| eGFR (mL/min/1.73 m2) | 27.8 (13.0) | 29.5 (12.8) |
| 30 to <60 (CKD Stage 3), n (%) | 47 (40.2) | 53 (46.1) |
| 15 to <30 (CKD Stage 4), n (%) | 55 (47.0) | 49 (42.6) |
| <15 (CKD Stage 5), n (%) | 15 (12.8) | 13 (11.3) |
| Hemoglobin (g/dL) | 10.4 (0.7) | 10.4 (0.8) |
| Transferrin saturation (%) | 20.2 (6.4) | 19.6 (6.6) |
| Ferritin (ng/mL) | 85.9 (55.7) | 81.7 (58.3) |
| Serum phosphate (mg/dL) | 4.2 (0.9) | 4.1 (0.7) |
| ≤3.8, n (%) | 43 (36.8) | 44 (38.3) |
| 3.9–4.4, n (%) | 38 (32.4) | 37 (32.1) |
| ≥4.5, n (%) | 36 (30.8) | 34 (29.6) |
| Calcium (mg/dL) | 9.3 (0.7) | 9.3 (0.7) |
| Bicarbonate (mEq/L) | 21.0 (3.9) | 21.6 (3.7) |
| Albumin (g/dL) | 4.0 (0.4) | 4.0 (0.4) |
| iPTH (pg/mL) | 103 [15–586] | 92 [21–551] |
| C-terminal FGF23 (RU/mL) | 364 [27–6480]b | 306 [34–8355]c |
| Intact FGF23 (pg/mL) | 134 [23–9562] | 134 [23–7253]a |
a
n = 114. bn = 116. cn = 113. Data are mean (SD) or median [min–max] unless otherwise specified.