Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03969329 | A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis | PHASE3 | RECRUITING | 24 | — | — | Dec 20, 2019 | Jun 30, 2027 | Mar 23, 2026 | 23 | Belgium, Czechia +10 |
| NCT03633708 | A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis | PHASE3 | RECRUITING | 56 | — | — | Apr 29, 2019 | Jan 31, 2029 | Feb 27, 2026 | 43 | United States, Argentina +8 |
| NCT03299244 | Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) | PHASE3 | COMPLETED | 637 | — | — | May 15, 2018 | Apr 8, 2020 | Apr 30, 2021 | 90 | China, Hong Kong +4 |
| NCT01896232 | Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet | PHASE3 | COMPLETED | 683 | — | — | Aug 13, 2013 | Jan 8, 2015 | Jul 18, 2019 | 182 | United States, Austria +20 |
| NCT03283098 | A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416 | PHASE1 | COMPLETED | 33 | — | — | Mar 1, 2018 | Feb 4, 2019 | Feb 10, 2020 | 5 | China |
To evaluate the efficacy of etelcalcetide in reducing the iPTH level in children ages equal to or greater than 2 to less than 18 years with SHPT receiving maintenance hemodialysis.
Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27).
Percent Change from Baseline in Mean iPTH During EAP (defined as weeks 20 through 27).
Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.
Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27.
Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session.
AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose.
Accumulation ratio, calculated as AUClast day 27/AUClast day 1.
| Arm | Type | Description |
|---|---|---|
| Etelcalcetide | EXPERIMENTAL | Participants will receive etelcalcetide in addition to standard of care. |
| Standard of Care | ACTIVE_COMPARATOR | Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone. |
| Cinacalcet | ACTIVE_COMPARATOR | Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL. |
| Placebo | PLACEBO_COMPARATOR | Intravenous (IV) administration of placebo three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Etelcalcetide | DRUG | Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, calcium (Ca), and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe. |
| Standard of Care | OTHER | Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders |
| Cinacalcet | DRUG | Cinacalcet administered orally once a day. |
| Oral Placebo | DRUG | Administered orally once a day. |
| Intravenous Placebo | DRUG | Administered intravenously (IV) three times per week. |
| Placebo | DRUG | Placebo supplied to match active intervention. |
Inclusion Criteria: * Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any trial-specific activiti...