Table 1.
Demographics and other characteristics at baseline (FAS)
| Patient characteristics | Evocalcet (n = 199) | Cinacalcet (n = 196) | Total (N = 395) | P-value |
|---|---|---|---|---|
| Agea, yrs, mean (SD) | 53.0 (12.13) | 52.0 (13.16) | 52.5 (12.65) | 0.449d |
| Median (min, max) | 54.0 (26, 79) | 53.0 (26, 90) | 53.0 (26, 90) | 0.425e |
| ≥65 yrs, n (%) | 40 (20.1) | 34 (17.3) | 74 (18.7) | 0.483f |
| Sex, n (%) | ||||
| Male | 125 (62.8) | 127 (64.8) | 252 (63.8) | 0.681f |
| Female | 74 (37.2) | 69 (35.2) | 143 (36.2) | |
| Region, n (%) | ||||
| China (including Hong Kong SAR) | 138 (69.3) | 136 (69.4) | 274 (69.4) | 0.877f |
| Taiwan | 22 (11.1) | 19 (9.7) | 41 (10.4) | |
| South Korea | 39 (19.6) | 41 (20.9) | 80 (20.3) | |
| Body mass indexb (kg/m2), mean ± SD | 24.0 ± 4.0 | 23.9 ± 4.1 | 24.0 ± 4.0 | 0.786d |
| Serum iPTH (pg/ml), mean ± SD | 778.4 ± 421.24 | 807.7 ± 517.67 | - | 0.537d |
| <500 | 53 (26.6) | 65 (33.2) | 118 (29.9) | 0.182f |
| 500–1000 | 98 (49.2) | 79 (40.3) | 177 (44.8) | |
| ≥1000 | 48 (24.1) | 52 (26.5) | 100 (25.3) | |
| Corrected serum Ca level (mg/dl) | 9.77 ± 0.653 | 9.73 ± 0.768 | - | 0.625d |
| Baseline serum P levelc (mg/dl) | 6.35 ± 1.633 | 6.35 ± 1.931 | 0.999 | |
| <5.5 | 61 (30.7) | 67 (34.2) | 128 (32.4) | 0.432f |
| ≥5.5 | 138 (69.3) | 128 (65.3) | 266 (67.3) | |
| Missing | 0 | 1 (0.5) | 1 (0.3) | |
| Use of cinacalcet hydrochloride | ||||
| Yes | 111 (55.8) | 111 (56.6) | 222 (56.2) | 0.864f |
| No | 88 (44.2) | 85 (43.4) | 173 (43.8) | |
| Use of active vitamin D preparations | ||||
| Yes | 119 (59.8) | 122 (62.2) | 241 (61.0) | 0.618f |
| No | 80 (40.2) | 74 (37.8) | 154 (39.0) | |
| Presence or absence of underlying diabetic nephropathy | ||||
| Yes | 17 (8.5) | 21 (10.7) | 38 (9.6) | 0.464f |
| No | 182 (91.5) | 175 (89.3) | 357 (90.4) | |
| Dialysis history (yrs) | ||||
| <10 | 123 (61.8) | 114 (58.2) | 237 (60.0) | 0.497f |
| ≥10 | 76 (38.2) | 81 (41.3) | 157 (39.7) | |
| Missing | 0 | 1 (0.5) | 1 (0.3) | |
| Ca concentration in dialysis solution (mEq/l) | ||||
| 2.5 | 49 (24.6) | 52 (26.5) | 101 (25.6) | 0.682f |
| 2.75 | 0 | 0 | 0 | |
| 3.0 | 143 (71.9) | 138 (70.4) | 281 (71.1) | |
| Other | 7 (3.5) | 6 (3.1) | 13 (3.3) | |
| Dialysis type | ||||
| HD | 120 (60.3) | 110 (56.1) | 230 (58.2) | 0.114f |
| HDF | 13 (6.5) | 6 (3.1) | 19 (4.8) | |
| Other | 66 (33.2) | 80 (40.8) | 146 (37.0) | |
| Initial dose of study drug | ||||
| Evocalcet 1 mg | 62 (31.2) | 65 (33.2) | 127 (32.2) | 0.540f |
| Evocalcet 2 mg | 137 (68.8) | 131 (66.8) | 268 (67.8) |
Ca, calcium; FAS, full analysis set; HD, hemodialysis; HDF, hemodiafiltration; P, phosphorus; PTH, parathyroid hormone; SAR, Special Administrative Region.
The percentage of patients in each category was relative to the total number of patients in the relevant analysis set.
a
Calculated relative to informed consent date for non-Koreans. Age was collected on case report forms for South Koreans.
b
Body mass index (kg/m2) = weight (kg) / height at baseline (m)2.
c
Baseline was defined as the last nonmissing measurement taken prior to the date of first administration of any study medication.
d
P-value based on t-test.
e
P-value based on generalized Wilcoxon test.
f
P-value based on chi-squared test.