Terminated/Withdrawn
Sponsor ID
20130356
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on dialysis
Study Details
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Protocol Summary
Primary Outcome Measures
Proportion of subjects who achieve a ≥ 30% reduction from baseline in mean plasma iPTH during Weeks 17 – 20
Timeframe: Week 17-20
US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH at Weeks 11 & 15
Timeframe: Weeks 11&15
Secondary Outcome Measures
Proportion of subjects who achieve a mean iPTH ≤ 300 pg/mL (31.8 pmol/L) during weeks 17-20
Timeframe: Week 17-20
Percent change in iPTH from baseline to the mean value during weeks 17-20
Timeframe: Week 17-20
Change in corrected total serum calcium from baseline to the mean value during weeks 17-20
Timeframe: Week 17-20
Change in serum phosphorus from baseline to the mean value during weeks 17-20
Timeframe: Week 17-20
US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH during Weeks 17-20
Timeframe: Week 17-20
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Marseille cedex 05, France, 13385
Status
Recruiting
Location
Research Site
Bronx, NY, United States, 10467
Status
Recruiting
Location
Research Site
Budapest, Hungary, 1083
Status
Recruiting
Location
Research Site
Cincinnati, OH, United States, 45229
Status
Recruiting
Location
Research Site
Columbus, OH, United States, 43205
Status
Recruiting
Location
Research Site
Espluques de LLobregat, Cataluña, Spain, 08950
Status
Recruiting
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