Table 3.
Summary of controlled etelcalcetide Phase II and III trials
| Study | Study design | Country/region | Study population (n) | Study duration | Comparator | Etelcalcetide intervention | Changes in iPTH: results of etelcalcetide vs comparator |
|---|---|---|---|---|---|---|---|
| Martin et al66 | Double-blind, randomized placebo-controlled, multicenter | USA | 28 (total) 12 (cohort 1–3) 16 (cohort 4–5) |
28 days | Placebo | Single dose of study drug Cohorts 1–3: two-period crossover design with 7–14 days interdose interval: cohort 1, 5 mg; cohort 2, 10 mg; cohort 3, 20 mg Cohorts 4 and 5: 1:1 randomization; cohort 4, 40 mg; cohort 5, 60 mg | Mean change from baseline at discharge (~3 days after application): cohort 3, −48.5%; cohort 4, −49.3%; cohort 5, −62.6% |
| Bell et al62 | Double-blind, randomized placebo- controlled, multicenter | USA | 78 | 2 weeks (cohort 1), 4 weeks (cohorts 2, 3) | Placebo | Cohort 1: 5 mg thrice weekly Cohort 2: 10 mg thrice weekly Cohort 3: 5 mg thrice weekly | Mean change from baseline to efficacy period: cohort 2, −49.4% (P<0.05); cohort 3, −33.0% (P<0.05) |
| Block et al64 | Two parallel, multicenter, randomized, double-blind, placebo-controlled trials | USA, Canada, Europe, Israel, Russia, Australia | 1,023 (trial A 508, trial B 515) | 26 weeks | Placebo | Starting dose 5 mg thrice weekly; titration in 2.5 or 5 mg increments at weeks 5, 9, 13, 17; maximum dose 15 mg thrice weekly | Proportion of patients achieving >30% reduction: trial A, 74.0% vs 8.3% (P<0.001); trial B, 75.3% vs 9.6% (P<0.001) |
| Block et al63 | Randomized, double-blind, double-dummy active clinical trial | USA, Canada, Europe, Russia, New Zealand | 683 | 26 weeks | Cinacalcet | Starting dose 5 mg thrice weekly, titration in increments of 2.5 or 5 mg at weeks 5, 9, 13, 17, maximum dose 15 mg Starting dose of oral cinacalcet 30 mg daily, titration in increments of 30 mg at weeks 5, 9, 13, 17, maximum dose 180 mg daily | Proportion of patients achieving >30% reduction: 68.2% vs 57.7% (noninferiority, P<0.001; superiority, P=0.004) |
| Fukagawa et al65 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group | Japan | 155 | 12 weeks | Placebo | Starting dose 5 mg thrice weekly, titration at 4-week intervals, maximum dose 15 mg thrice weekly | Proportion of patients achieving target range of 60–240 pg/mL: 59.0% vs 1.3% (P<0.001) |
Abbreviation: iPTH, intact parathyroid hormone.