At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Cinacalcetdrug
Likely dose
Cinacalcet 0.25 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 Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis
In Brief
A Phase 1 clinical trial evaluating Cinacalcet for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 14 participants across 10 sites in 3 countries.
Detailed Summary
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionSep 2015
TodayJul 2026
First PostedFeb 4, 2011
Enrollment StartJan 25, 2011
Primary CompletionSep 23, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.4 years ago
Interventions
Cinacalcetdrug
Single, oral dose of 0.25 mg/kg cinacalcet