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Trials / Completed

CompletedNCT01290029

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Amgen · Industry
Sex
All
Age
28 Days – 2190 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCinacalcetSingle, oral dose of 0.25 mg/kg cinacalcet

Timeline

Start date
2011-01-25
Primary completion
2015-09-23
Completion
2015-09-23
First posted
2011-02-04
Last updated
2020-06-17
Results posted
2016-12-19

Locations

10 sites across 3 countries: United States, Germany, United Kingdom

Source: ClinicalTrials.gov record NCT01290029. Inclusion in this directory is not an endorsement.

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease (NCT01290029) · Clinical Trials Directory