Spots Global Cancer Trial Database for Pediatric Chronic Kidney Disease Safety and Efficacy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Pediatric Chronic Kidney Disease Safety and Efficacy
Official Title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
Study ID: NCT01277510
Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Detailed Description: Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.
Eligibility
Minimum Age: 6 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Los Angeles, California, United States
Research Site, San Francisco, California, United States
Research Site, Gainesville, Florida, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, 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, Livingston, New Jersey, United States
Research Site, Bronx, New York, United States
Research Site, Greenville, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Houston, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Charlottesville, Virginia, United States
Research Site, Randwick, New South Wales, Australia
Research Site, Westmead, New South Wales, Australia
Research Site, Herston, Queensland, Australia
Research Site, Parkville, Victoria, Australia
Research Site, Bruxelles, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Heidelberg, , Germany
Research Site, Marburg, , Germany
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Pecs, , Hungary
Research Site, Szeged, , Hungary
Research Site, Mexico, Distrito Federal, Mexico
Research Site, Aguascalientes, , Mexico
Research Site, Gdansk, , Poland
Research Site, Gorzow Wielkopolski, , Poland
Research Site, Lodz, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, Banska Bystrica, , Slovakia
Research Site, Bratislava, , Slovakia
Research Site, Kosice, , Slovakia
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, Baracaldo, PaÃ-s Vasco, Spain
Research Site, Baracaldo, País Vasco, Spain
Research Site, Madrid, , Spain
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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