At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 637 enrolled
Drug / intervention
Etelcalcetide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
In Brief
A Phase 3 clinical trial evaluating Etelcalcetide and Cinacalcet for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 637 participants across 90 sites in 6 countries.
Detailed Summary
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Hong Kong, India, Malaysia, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartMay 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedOct 3, 2017
Enrollment StartMay 15, 2018
Primary CompletionApr 8, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.7 years ago
Interventions
Etelcalcetidedrug
Administered intravenously three times per week.
Cinacalcetdrug
Cinacalcet administered orally once a day.