Table 1. Baseline characteristics and exposure.
| Placebo-Controlled Trials | Active-Controlled Trial | Open-Label Extension Trials | |||
|---|---|---|---|---|---|
| Placebo (n = 514) n (%) |
Etelcalcetide (n = 509) n (%) |
Cinacalcet (n = 343) n (%) |
Etelcalcetide (n = 340) n (%) |
Etelcalcetide (n = 1299) n (%) |
|
| Mean (SD) age, year | 58.1 (14.3) | 58.4 (14.6) | 55.3 (14.41) | 54.0 (13.81) | 56.8 (14.2) |
| Men, % | 305 (59.3) | 313 (61.5) | 192 (56.0) | 192 (56.5) | 781 (60.1) |
| Race, % | |||||
| White | 344 (66.9) | 336 (66.0) | 277 (80.8) | 261 (76.8) | 900 (69.3) |
| Black | 149 (29.0) | 136 (26.7) | 52 (15.2) | 54 (15.9) | 329 (25.3) |
| Other | 21 (4.1) | 37 (7.3) | 14 (4.1) | 25 (7.4) | 70 (5.4) |
| Median (Q1–Q3) time since initiation of dialysis, year | 3.8 (1.8–6.9) | 4.0 (2.0–7.8) | 4.1 (1.7–7.5) | 4.4 (2.0–7.8) | N/A |
| Median (Q1–Q3) PTH, pg/mL | 716 (557–982) | 724 (552–949) | 930 (694–1327) | 900 (685–1266) | N/A |
| Mean (SD) phosphate concentration, mg/dL | 5.80 (1.53) | 5.86 (1.59) | 5.82 (1.58) | 5.81 (1.69) | N/A |
| Mean (SD) calcium, albumin-corrected, mg/dL | 9.65 (0.65) | 9.64 (0.66) | 9.58 (0.67) | 9.67 (0.71) | N/A |
| Received ≥ 1 dose of investigational product | 513 | 503 | 341 | 338 | 1298 |
| Median (range) length of exposure, day | — | 181.0 (1–190) | 181.0 (3–197) | 181.0 (1–190) | 618.0 (1–1063) |
| Median (IQR) average weekly dose during EAP, mg/week | — | 20.4 (8.9–30.0) | 360.0 (185.0–562.9) | 15.0 (9.2–30.0) | — |
EAP = efficacy assessment phase; N/A = not available; PTH = parathyroid hormone.