Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
NCT01290029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2020-06-17
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
- Chronic Kidney Disease
- Hyperparathyroidism, Secondary
- Secondary Hyperparathyroidism
Interventions
- DRUG
-
Cinacalcet
Single, oral dose of 0.25 mg/kg cinacalcet
Sponsors & Collaborators
- lead INDUSTRY
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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