Spots Global Cancer Trial Database for Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
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Trial Identification
Brief Title: Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Official Title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
Study ID: NCT01439867
Study Description
Brief Summary: The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Detailed Description: This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first. The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes. Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
Eligibility
Minimum Age: 28 Days
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Los Angeles, California, United States
Research Site, Iowa City, Iowa, United States
Research Site, Louisville, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Kansas City, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Bronx, New York, United States
Research Site, Greenville, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Oklahoma City, Oklahoma, 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, 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, Paris, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Heidelberg, , Germany
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Szeged, , Hungary
Research Site, Genova, , Italy
Research Site, Roma, , Italy
Research Site, Torino, , Italy
Research Site, Chihuahua, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Grafton, Auckland, , New Zealand
Research Site, Gdansk, , Poland
Research Site, Krakow, , Poland
Research Site, Warszawa, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Kosice, , Slovakia
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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