Spots Global Cancer Trial Database for Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
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Trial Identification
Brief Title: Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Official Title: A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
Study ID: NCT02138838
Study Description
Brief Summary: The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Detailed Description: This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to \< 12 and 12 to \< 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders. Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.
Eligibility
Minimum Age: 6 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Los Angeles, California, United States
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, Saint Louis, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, West Orange, New Jersey, United States
Research Site, Bronx, New York, United States
Research Site, New York, 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, Salt Lake City, Utah, United States
Research Site, Bruxelles, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Praha 5, , Czechia
Research Site, Bron cedex, , France
Research Site, Lille, , France
Research Site, Marseille cedex 05, , France
Research Site, Nice cedex 3, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Marburg, , Germany
Research Site, Athens, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Budapest, , Hungary
Research Site, Szeged, , Hungary
Research Site, Genova, , Italy
Research Site, Napoli, , Italy
Research Site, Torino, , Italy
Research Site, Vilinus, , Lithuania
Research Site, Grafton, Auckland, , New Zealand
Research Site, Krakow, , Poland
Research Site, Lodz, , Poland
Research Site, Warszawa, , Poland
Research Site, Porto, , Portugal
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, Kosice, , Slovakia
Research Site, Barcelona, Cataluña, Spain
Research Site, Espluques De LLobregat, Cataluña, Spain
Research Site, Kyiv, , Ukraine
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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