At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 902 enrolled
Drug / intervention
Etelcalcetidedrug
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 Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
In Brief
A Phase 3 clinical trial evaluating Etelcalcetide for Hyperparathyroidism, Secondary. Completed, enrolled 902 participants across 228 sites in 24 countries.
Detailed Summary
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperparathyroidism, Secondary
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedApr 2014
Primary CompletionNov 2016
Study CompletionJun 2017
TodayJul 2026
First PostedApr 2, 2014
Enrollment StartMar 25, 2014
Primary CompletionNov 4, 2016
Study CompletionJun 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.3 years ago
Interventions
Etelcalcetidedrug
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.