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Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

NCT01439867 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-06-17

Study results available
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Summary

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Conditions

Interventions

DRUG

Cinacalcet hydrochloride

Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.

DRUG

Standard of Care

Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
2189 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-22
Primary Completion
2016-06-03
Completion
2016-06-03

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01439867 on ClinicalTrials.gov