A Study to Assess the Efficacy and Safety of Cinacalcet in Pediatric Subjects With SHPT and CKD on Dialysis
Conditions
Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions: official terms
Hyperparathyroidism - Hyperparathyroidism, Secondary - Kidney Diseases - Neoplasm Metastasis - Renal Insufficiency, Chronic
Conditions: Keywords
Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cinacalcet HCl Type: Drug
Name: Standard of Care Type: Dietary Supplement
Overall Status
Recruiting
Summary
This is a phase 3, 24-week, randomized, multicenter, open-label, controlled study. subjects will be randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment arm or a standard of care arm. Randomization will be stratified by age group. All subjects receive standard of care which can include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 17 Years
Minimum Age: 6 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 6 - < 18 years

- Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening

- Corrected calcium value of ≥ 8.8 mg/dL during screening

- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening

- Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines

Exclusion Criteria:

- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval

- Corrected QT interval (QTc) > 500 ms, using Bazett's formula

- QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist

- Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)

- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Locations
Research Site
Los Angeles, California, United States
Status: Recruiting
Research Site
Atlanta, Georgia, United States
Status: Recruiting
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Iowa City, Iowa, United States
Status: Recruiting
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Louisville, Kentucky, United States
Status: Recruiting
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Baltimore, Maryland, United States
Status: Recruiting
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Boston, Massachusetts, United States
Status: Recruiting
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Minneapolis, Minnesota, United States
Status: Recruiting
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Jackson, Mississippi, United States
Status: Recruiting
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Kansas City, Missouri, United States
Status: Recruiting
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Saint Louis, Missouri, United States
Status: Recruiting
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St. Louis, Missouri, United States
Status: Recruiting
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Livingston, New Jersey, United States
Status: Recruiting
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Bronx, New York, United States
Status: Recruiting
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New York, New York, United States
Status: Recruiting
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Greenville, North Carolina, United States
Status: Recruiting
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Cincinnati, Ohio, United States
Status: Recruiting
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Cleveland, Ohio, United States
Status: Recruiting
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Columbus, Ohio, United States
Status: Recruiting
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Houston, Texas, United States
Status: Recruiting
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San Antonio, Texas, United States
Status: Recruiting
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Salt Lake City, Utah, United States
Status: Recruiting
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Bruxelles, Belgium
Status: Recruiting
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Gent, Belgium
Status: Recruiting
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Leuven, Belgium
Status: Recruiting
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Praha 5, Czech Republic
Status: Recruiting
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Bron cedex, France
Status: Recruiting
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Marseille cedex 05, France
Status: Recruiting
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Paris, France
Status: Recruiting
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Paris, France
Status: Recruiting
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Hannover, Germany
Status: Recruiting
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Heidelberg, Germany
Status: Recruiting
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Marburg, Germany
Status: Recruiting
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Athens, Greece
Status: Recruiting
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Thessaloniki, Greece
Status: Recruiting
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Budapest, Hungary
Status: Recruiting
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Szeged, Hungary
Status: Recruiting
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Genova, Italy
Status: Recruiting
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Napoli, Italy
Status: Recruiting
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Torino, Italy
Status: Recruiting
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Vilinus, Lithuania
Status: Recruiting
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Grafton, Auckland, New Zealand
Status: Recruiting
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Krakow, Poland
Status: Recruiting
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Lodz, Poland
Status: Recruiting
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Warszawa, Poland
Status: Recruiting
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Porto, Portugal
Status: Recruiting
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Moscow, Russian Federation
Status: Recruiting
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Saint Petersburg, Russian Federation
Status: Recruiting
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Samara, Russian Federation
Status: Recruiting
Research Site
Kosice, Slovakia
Status: Recruiting
Research Site
Barcelona, Cataluña, Spain
Status: Recruiting
Research Site
Espluques de LLobregat, Cataluña, Spain
Status: Recruiting
Research Site
Kyiv, Ukraine
Status: Recruiting
Start Date
November 2014
Completion Date
February 2016
Sponsors
Amgen
Source
Amgen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page