Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

NCT01290029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-06-17

Study results available
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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

DRUG

Cinacalcet

Single, oral dose of 0.25 mg/kg cinacalcet

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
2190 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-25
Primary Completion
2015-09-23
Completion
2015-09-23

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290029 on ClinicalTrials.gov