Table 1.
Baseline Characteristics of Study Population Prior to Randomization
| Ferric Citrate (n = 292) | Active Control (n = 149) | |
|---|---|---|
| Age (y) | 54.9 ± 13.4 | 53.7 ± 13.0 |
| Male sex | 183 (62.7) | 87 (58.4) |
| Race | ||
| Black/African American | 154 (52.7) | 78 (52.4) |
| White/Caucasian | 124 (42.5) | 62 (41.6) |
| Other/unknown | 14 (4.8) | 9 (6.0) |
| Hispanic or Latino ethnicity | 43 (14.8) | 23 (15.4) |
| Cause of ESRD | ||
| Diabetic nephropathy | 120 (41.1) | 65 (43.6) |
| Hypertensive nephrosclerosis | 89 (30.5) | 45 (30.2) |
| Glomerular disease or other | 83 (28.4) | 39 (26.2) |
| Peritoneal dialysis | 11 (2.5) | 3 (0.7) |
| Vitamin D/vitamin D analogue use | 223 (76.4) | 126 (84.6) |
| Phosphate-binder use at screening | ||
| Sevelamer | 170 (58.2) | 96 (64.4) |
| Calcium acetate | 104 (36.0) | 57 (38.3) |
| Lanthanum carbonate | 28 (9.6) | 12 (8.1) |
| Calcium carbonate | 15 (5.2) | 13 (8.7) |
| Other | 5 (1.7) | 1 (0.7) |
| Parathyroidectomy | 19 (6.6) | 4 (2.7) |
| Calcium (mg/dL) | 9.00 [8.40-9.45] | 9.00 [8.50-9.58] |
| Phosphorus (mg/dL) | 7.20 [6.30-8.30] | 7.40 [6.20-8.50] |
| Calcium-phosphorus product (mg2/dL2) | 63.51 [54.60-75.57] | 66.18 [56.15-75.84] |
| Intact PTH (pg/mL) | 514 [331-794] | 479 [278-755] |
| Serum bicarbonate (mmol/L) | 24 [22.0-26.0] | 24 [22.0-26.0] |
| SUN (mg/dL) | 55 [45.0-65.5] | 56 [44.5-68.5] |
| Serum albumin (g/dL) | 4.0 [3.8-4.2] | 4.0 [3.8-4.2] |
| Total cholesterol (mg/dL) | 151.0 [128.0-180.0] | 148.0 [125.5-176.0] |
| LDL cholesterol (mg/dL) | 79.0 [62-103.0] | 80.0 [64.0-99.0] |
| White blood cell count (×103) | 6.54 [5.31-7.9] | 6.36 [5.06-7.88] |
| Lymphocytes (%) | 21.3 [16.1-26.6] | 20.2 [16.8-27.4] |
Note: Values for categorical variables are given as number (percentage); values for continuous variables, as mean ± standard deviation or median [interquartile range]. Conversion factors for units: calcium in mg/dL to mmol/L, ×0.2495; cholesterol in mg/dL to mmol/L, ×0.02586; phosphorus in mg/dL to mmol/L, ×0.3229; SUN in mg/dL to mmol/L, ×0.357.
Abbreviations: ESRD, end-stage renal disease; LDL, low-density lipoprotein; PTH, parathyroid hormone; SUN, serum urea nitrogen.