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Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

NCT02138838 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-06-29

Study results available
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Summary

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Conditions

  • Chronic Kidney Disease, Secondary Hyperparathyroidism

Interventions

DRUG

Cinacalcet HCl

Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.

DIETARY_SUPPLEMENT

Standard of Care

Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-07
Primary Completion
2016-06-23
Completion
2016-06-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT02138838 on ClinicalTrials.gov