At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 11 enrolled
Drug / intervention
Etelcalcetidedrug
Likely dose
Etelcalcetide 0.035 mg/kgfrom 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.
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
In Brief
A Phase 1 clinical trial evaluating Etelcalcetide for Chronic Kidney Disease, Secondary Hyperparathyroidism. Completed, enrolled 11 participants across 13 sites in 6 countries.
Detailed Summary
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Lithuania, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartMar 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedJul 14, 2016
Enrollment StartMar 14, 2017
Primary CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.0 years ago
Interventions
Etelcalcetidedrug
A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.