At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 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, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
In Brief
A Phase 3 clinical trial evaluating Etelcalcetide for Hyperparathyroidism, Secondary. Completed, enrolled 158 participants across 40 sites.
Detailed Summary
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperparathyroidism, Secondary
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionJan 2014
Study CompletionFeb 2017
TodayJul 2026
First PostedAug 30, 2013
Enrollment StartAug 12, 2013
Primary CompletionJan 14, 2014
Study CompletionFeb 14, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.8 years ago
Interventions
Etelcalcetidedrug
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.