At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 891 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 Efficacy and 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 891 participants across 208 sites in 17 countries.
Detailed Summary
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperparathyroidism, Secondary
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartJul 2013
Primary CompletionJul 2015
TodayJul 2026
First PostedFeb 7, 2013
Enrollment StartJul 31, 2013
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.4 years ago
Interventions
Etelcalcetidedrug
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).