Table 1.
Demographic and baseline characteristics of the study patients
| Patient characteristics | Classification | Etelcalcetide | Placebo |
|---|---|---|---|
| Number of patients, n | 78 | 77 | |
| Sex, n (%) | Male | 48 (61.5) | 52 (67.5) |
| Female | 30 (38.5) | 25 (32.5) | |
| Age (years) | Mean ± SD | 62.1 ± 9.9 | 60.6 ± 12.3 |
| Median | 64.0 | 61.0 | |
| Range | 37–83 | 22–86 | |
| Body weight (kg) (post-dialysis) | Mean ± SD | 59.27 ± 11.63 | 62.22 ± 13.07 |
| Median | 58.40 | 61.20 | |
| Range | 39.2–97.2 | 39.1–104.0 | |
| BMI (kg/m2) | Mean ± SD | 22.67 ± 3.55 | 23.12 ± 3.55 |
| Median | 22.15 | 22.85 | |
| Range | 16.3–34.2 | 14.8–33.2 | |
| Duration of dialysis (years) | Mean ± SD | 11.9 ± 7.3 | 11.8 ± 7.8 |
| Median | 11.0 | 11.0 | |
| Range | 1–41 | 1–32 | |
| Use of active vitamin D, n (%) | Yes | 63 (80.8) | 67 (87.0) |
| No | 15 (19.2) | 10 (13.0) | |
| Use of phosphate binder, n (%) | Yes | 74 (94.9) | 72 (93.5) |
| No | 4 (5.1) | 5 (6.5) | |
| Serum iPTH (pg/mL) | Mean ± SD | 536.2 ± 245.7 | 568.1 ± 354.1 |
| Median | 484.0 | 504.0 | |
| Range | 222–1470 | 209–2620 | |
| Serum cCa (mg/dL) | Mean ± SD | 9.58 ± 0.65 | 9.48 ± 0.76 |
| Median | 9.60 | 9.50 | |
| Range | 8.2–11.1 | 7.8–11.1 | |
| Serum P (mg/dL) | Mean ± SD | 5.94 ± 1.44 | 6.33 ± 1.41 |
| Median | 5.80 | 6.20 | |
| Range | 3.4–10.7 | 3.4–11.4 | |
| Serum BAP (µg/L) | Mean ± SD | 19.35 ± 8.96 | 19.56 ± 10.62 |
| Median | 16.80 | 16.60 | |
| Range | 7.5–64.5 | 7.9–78.3 | |
| Serum TRACP-5b (mU/dL) | Mean ± SD | 854.5 ± 351.5 | 873.3 ± 344.5 |
| Median | 791.5 | 864.0 | |
| Range | 279–1990 | 244–1780 | |
| Serum iFGF23 (pg/mL) | Mean ± SD | 22 769.7 ± 39 726.9 | 23 928.5 ± 38 857.2 |
| Median | 9050.0 | 11800.0 | |
| Q1, Q3 | 3300.0, 26 100.0 | 4500.0, 28 400.0 |
BMI, body mass index; SD, standard deviation.