Table 3.
Phases 2 and 3 efficacy data
| 20070208 | 20130356 | 20110100 | 20140159 | ||||
|---|---|---|---|---|---|---|---|
| Cinacalcet (n = 22) | PBO (n = 21) | Cinacalcet + SOC (n = 27) | SOC (n = 28) | Cohort 1 (n = 7) | Cohort 2 (n = 10) | Cinacalceta (n = 13) | |
| PTH (pg/mL) | |||||||
|
Baseline levels Mean (SD) Median (range) |
757 (440) |
796 (538) 684 (300–2246) |
946 (635) 663 (347–2924) |
1228 (732) 1123 (300–2701) |
1428 (755) 1294 (521–2903) |
1207 (598) 1158 (396–2347) |
n/a |
| 676 (309–2407) | |||||||
| Subjects achieving a ≥ 30% reduction, n/N (%) | 12/22 (54.5) | 4/21 (19.0) |
7/27 (25.9)b 6/27 (22.2)c |
5/28 (17.9)b 9/28 (32.1)c |
7/7 (100) | 5/10 (50) |
4/13 (30.8)d 3/13 (23.1)e |
| Subjects achieving a PTH value ≤300 pg/mL, n/N (%) | 6/22 (27.3) | 5/21 (23.8) | 2/27 (7.4)f | 5/28 (17. 9)f | 4/7 (57.1) | 5/10 (50) | 1/13 (7.7)e |
| Corrected Calcium (mg/dL) | |||||||
|
Baseline levels Mean (SD) Median (range) |
9.9 (0.5) 10.1 (8.9–10.8) |
9.9 (0.6) 9.8 (9.0–11.3) |
9.8 (0.6) 9.7 (8.9–11.8) |
9.8 (0.6) 9.8 (8.9–11.0) |
10.5 (0.8) 10.3 (9.3–11.5) |
9.8 (0.6) 9.8 (8.9–10.9) |
9.7 (0.4) 9.6 (9.2–10.4) |
| LS mean (95% CI) percentage change |
− 4.6 (− 8.4, − 0.9) |
− 1.0 (− 4.9, 2.9) |
− 2.7 (− 5.4, − 0.1)f |
0.7 (− 1.8, 3.2)f |
− 0.5 (-3.8, 2.15)g − 3.6 (-10.9, 3.7)h |
− 3.3 (-0.9,10.5)g 3.6 (-3.3, 11.5)h |
− 1.4 (− 4.5, 1.5)i |
| Phosphate, mg/dL | |||||||
|
Baseline levels Mean (SD) Median (range) |
6.7 (1.8) 6.7 (3.7–12.1) |
6.4 (1.5) 6.0 (4.5–10.6) |
5.9 (1.4) 5.9 (3.5–10.0) |
5.7 (1.1) 5.5 (3.3–8.2) |
6.0 (2.2) 5.2 (4.6–10.8) |
6.4 (1.3) 6.0 (4.5–9.0) |
5.5 (1.1) 5.6 (4.0–7.1) |
| LS mean (95% CI) percentage change |
2.9 (− 8.0, 13.8) |
9.3 (− 2.0, 20.6) |
13.6 (4.1, 23.0)f |
− 0.8 (− 10.0, 8.4)f |
− 10.8 (− 33.9, 10.3)h − 8.7 (− 25.8, 8.5)j |
− 5.1 (− 31.7, 5.6)g − 9.6 (− 24.7, 13.7)h |
− 2.1 (− 10.3, 8.2)i |
aEfficacy data from cinacalcet + SOC treated subjects in the parent study (Study 20130356) are presented above therefore, efficacy data here focus only on those subjects (n = 13) who received SOC in the parent study and subsequently received cinacalcet in the extension study. bWeeks 11 and 15 (the US primary endpoint); cWeeks 17 to 20 (US secondary endpoint/global primary endpoint); dDuring weeks 11 and 15; e During weeks 23 and 28; f Weeks 17 to 20 (secondary endpoint); g Mean (Q1, Q3) presented; h Mean (Q1, Q3) percent change from baseline at Week 3 presented (n = 17); i Median (Q1, Q3) presented; j Mean (Q1, Q3) percentage change from baseline at Week 7 presented (n = 12). Ca, calcium; CI, confidence interval; n/a, not applicable; P, phosphate; PTH, parathyroid hormone; SD, standard deviation; SOC, standard of care