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Pediatric Chronic Kidney Disease Safety and Efficacy

NCT01277510 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-06-29

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Conditions

Interventions

DRUG

cinacalcet capsule

Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

DRUG

placebo

Placebo tablets and capsules for sprinkling identical to active treatment.

DRUG

Standard of Care

All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-28
Primary Completion
2014-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT01277510 on ClinicalTrials.gov