At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 28 enrolled
Drug / intervention
Cinacalcetdrug
Likely dose
Cinacalcet 5 mgfrom 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 Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
In Brief
A Phase 3 clinical trial evaluating Cinacalcet for Secondary Hyperparathyroidism, Chronic Kidney Disease. Completed, enrolled 28 participants across 33 sites in 11 countries.
Detailed Summary
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartJun 2015
Primary CompletionMar 2017
TodayJul 2026
First PostedJan 19, 2015
Enrollment StartJun 10, 2015
Primary CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.5 years ago
Interventions
Cinacalcetdrug
Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.