Table 2.
Lead-in study baseline demographics, key laboratory values, and medical history of subjects of the extension study
| Characteristic | Original Cinacalcet (n = 334) | Original Placebo (n = 255) |
|---|---|---|
| Sex, n (%) | ||
| Male | 210 (63) | 166 (65) |
| Female | 124 (37) | 89 (35) |
| Race, n (%) | ||
| White | 159 (48) | 157 (62) |
| Black | 123 (37) | 70 (27) |
| Other | 52 (16) | 28 (11) |
| Age | ||
| Mean (SD), years | 50.9 (14.1) | 53.3 (14.9) |
| Median (Q1, Q3), years | 51.0 (40.0, 61.0) | 53.0 (41.0, 65.0) |
| <65 yr, n (%) | 273 (82) | 189 (74) |
| ≥65 yr, n (%) | 61 (18) | 66 (26) |
| Duration of dialysisa, months | ||
| Mean (SD) | 69.6 (62.4) | 71.7 (69.2) |
| Median (Q1, Q3) | 51.0 (23.0, 94.0) | 47.0 (23.0, 90.0) |
| PTH, pg/ml | ||
| Mean (SD) | 773.50 (651.34) | 693.82 (392.20) |
| Median (Q1, Q3) | 613.08 (435.20, 870.78) | 583.00 (425.96, 794.00) |
| Serum calcium, mg/dl | ||
| Mean (SD) | 9.83 (0.80) | 9.88 (0.81) |
| Median (Q1, Q3) | 9.80 (9.27, 10.27) | 9.83 (9.24, 10.49) |
| Serum phosphorus, mg/dl | ||
| Mean (SD) | 6.23 (1.70) | 6.11 (1.50) |
| Median (Q1, Q3) | 6.00 (5.10, 7.27) | 6.12 (5.00, 7.03) |
| Ca × Pb, mg2/dl2 | ||
| Mean (SD) | 61.01 (16.45) | 60.27 (15.00) |
| Median (Q1, Q3) | 58.99 (48.78, 71.46) | 60.18 (50.72, 69.91) |
| PTH ≤300 pg/ml + Ca×P ≤55 mg2/dl2, n (%) | 1 (<1) | 0 (0) |
| Co-existing diabetes, n (%) | ||
| Yes | 93 (28) | 74 (29) |
| No | 241 (72) | 181 (71) |
| Hypertension, n (%) | ||
| Yes | 317 (95) | 242 (95) |
| No | 17 (5) | 13 (5) |
| Coronary artery disease, n (%) | ||
| Yes | 91 (27) | 65 (25) |
| No | 243 (73) | 190 (75) |
| Congestive heart failure, n (%) | ||
| Yes | 77 (23) | 39 (15) |
| No | 257 (77) | 216 (85) |
| Myocardial infarction, n (%) | ||
| Yes | 43 (13) | 36 (14) |
| No | 291 (87) | 219 (86) |
| Peripheral vascular disease, n (%) | ||
| Yes | 55 (16) | 47 (18) |
| No | 279 (84) | 208 (82) |
| Cerebrovascular accident, n (%) | ||
| Yes | 28 (8) | 30 (12) |
| No | 306 (92) | 225 (88) |
a
Data unavailable for 19 subjects in original cinacalcet group and two subjects in original placebo group.
b
Data unavailable for one subject in original cinacalcet group.