Table 1.
Baseline characteristics of participants in a randomized clinical trial of upacicalcet in Japan
| Participant Characteristics | Classification | Upacicalcet (n=103) | Placebo (n=50) |
|---|---|---|---|
| Sex, n (%) | Male | 77 (75) | 39 (78) |
| Female | 26 (25) | 11 (22) | |
| Age, yr | Mean±SD | 62±13 | 66±14 |
| ≥65 | 55 (53) | 30 (60) | |
| Primary disease, n (%) | Chronic glomerulonephritis | 36 (35) | 24 (48) |
| Diabetic kidney disease | 33 (32) | 10 (20) | |
| Nephrosclerosis | 13 (13) | 5 (10) | |
| Polycystic kidney disease | 2 (2) | 1 (2) | |
| Other, including unknown | 19 (18) | 10 (20) | |
| Duration of dialysis, yr, n (%) | Mean±SD | 10±8 | 8±7 |
| <5 | 35 (34) | 25 (50) | |
| 5–9 | 21 (20) | 6 (12) | |
| 10–19 | 32 (31) | 16 (32) | |
| ≥20 | 15 (15) | 3 (6) | |
| Dialysate calcium concentration, mEq/L, n (%) | 2.5 | 32 (31) | 14 (28) |
| 2.75 | 39 (38) | 21 (42) | |
| 3.0 | 32 (31) | 15 (30) | |
| Use of vitamin D receptor activators, n (%) | No | 27 (26) | 7 (14) |
| Yes | 76 (74) | 43 (86) | |
| Use of calcium carbonate, n (%) | No | 56 (54) | 29 (58) |
| Yes | 47 (46) | 21 (42) | |
| Use of non–calcium-containing phosphate binders, n (%) | No | 15 (15) | 10 (20) |
| Yes | 88 (85) | 40 (80) | |
| Prior use of calcimimetics, n (%) | Cinacalcet | 16 (16) | 12 (24) |
| Etelcalcetide | 3 (3) | 2 (4) | |
| Evocalcet | 39 (38) | 13 (26) | |
| None | 45 (44) | 23 (46) | |
| Serum intact parathyroid hormone, pg/ml | Median (Q1, Q3) | 364 (306, 463) | 369.5 (302, 457) |
| Category of serum intact parathyroid hormone, pg/ml | ≤240 | 5 (5) | 4 (8) |
| 241–499 | 79 (77) | 38 (76) | |
| ≥500 | 19 (18) | 8 (16) | |
| Serum corrected calcium, mg/dl | Mean±SD | 9.3±0.7 | 9.4±0.7 |
| Category of serum corrected calcium, mg/dl, n (%) | <8.4 | 2 (2) | 2 (4) |
| 8.4–8.9 | 37 (36) | 15 (30) | |
| 9.0–10.0 | 49 (48) | 23 (46) | |
| >10.0 | 15 (15) | 10 (20) | |
| Serum phosphate, mg/dl | Mean±SD | 6.0±1.4 | 6.2±1.6 |
| Serum fibroblast growth factor 23, pg/ml | Median (Q1, Q3) | 8670 (2080, 18,900) | 8485 (3700, 28,700) |
| Serum bone alkaline phosphatase, µg/L | Median (Q1, Q3) | 15.7 (12.1, 20.9) | 15.5 (11.6, 20.5) |
| Serum N-terminal propeptide of type 1 procollagen, ng/ml | Median (Q1, Q3) | 356 (243, 493) | 330.5 (205, 472) |
| Serum tartrate-resistant acid phosphatase-5b, mU/dl | Median (Q1, Q3) | 723 (495, 963) | 717 (415, 980) |
Data are shown as number (percentage), mean±SD, or median (25%tile, 75%tile).