Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Stopped early · Phase 3
Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism
In brief
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Key facts
- Study ID
- NCT02138838
- Run by
- Amgen
- People needed
- 55
- Starts
- 2014-11-07
- Expected to finish
- 2016-06-23
- Last updated by the study team
- 2020-06-29
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Where it is running
- Research Site — Wilmington, Delaware, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Iowa City, Iowa, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — Baltimore, Maryland, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Minneapolis, Minnesota, United States
- Research Site — Jackson, Mississippi, United States
- Research Site — Kansas City, Missouri, United States
- Research Site — St Louis, Missouri, United States
- Research Site — St Louis, Missouri, United States
- Research Site — West Orange, New Jersey, United States
- Research Site — New York, New York, United States
- Research Site — The Bronx, New York, United States
- Research Site — Greenville, North Carolina, United States
- Research Site — Cincinnati, Ohio, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Dallas, Texas, United States
- Research Site — Houston, Texas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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