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Clinical Trial Details

Trial ID: L0642
Source ID: NCT02138838
Associated Drug: Cinacalcet Hcl
Title: Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02138838/results
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Interventions: DRUG: Cinacalcet HCl|DIETARY_SUPPLEMENT: Standard of Care
Outcome Measures: Primary: Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15, Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only., Baseline and weeks 11 to 15|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period, Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint., Baseline and the efficacy assessment period (EAP), weeks 17 to 20 | Secondary: Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20, Efficacy assessment period, weeks 17 to 20|Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20, Baseline and weeks 17 to 20|Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20, Baseline and weeks 17 to 20|Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20, Baseline and weeks 17 to 20
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 55
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-11-07
Completion Date: 2016-06-23
Results First Posted: 2017-09-14
Last Update Posted: 2020-06-29
Locations: Research Site, Los Angeles, California, 90027, United States|Research Site, Wilmington, Delaware, 19803, United States|Research Site, Atlanta, Georgia, 30322, United States|Research Site, Chicago, Illinois, 60612, United States|Research Site, Iowa City, Iowa, 52242, United States|Research Site, Louisville, Kentucky, 40202, United States|Research Site, Baltimore, Maryland, 21287, United States|Research Site, Boston, Massachusetts, 02115, United States|Research Site, Detroit, Michigan, 48201, United States|Research Site, Minneapolis, Minnesota, 55454, United States|Research Site, Jackson, Mississippi, 39216, United States|Research Site, Kansas City, Missouri, 64108, United States|Research Site, Saint Louis, Missouri, 63104, United States|Research Site, Saint Louis, Missouri, 63110, United States|Research Site, West Orange, New Jersey, 07052, United States|Research Site, Bronx, New York, 10467, United States|Research Site, New York, New York, 10029, United States|Research Site, Greenville, North Carolina, 27834, United States|Research Site, Cincinnati, Ohio, 45229, United States|Research Site, Cleveland, Ohio, 44106, United States|Research Site, Columbus, Ohio, 43205, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Dallas, Texas, 75235, United States|Research Site, Houston, Texas, 77030, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Salt Lake City, Utah, 84113, United States|Research Site, Bruxelles, 1020, Belgium|Research Site, Gent, 9000, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Praha 5, 150 06, Czechia|Research Site, Bron cedex, 69677, France|Research Site, Lille, 59800, France|Research Site, Marseille cedex 05, 13385, France|Research Site, Nice cedex 3, 06202, France|Research Site, Paris, 75012, France|Research Site, Paris, 75015, France|Research Site, Paris, 75019, France|Research Site, Hannover, 30625, Germany|Research Site, Heidelberg, 69120, Germany|Research Site, Marburg, 35043, Germany|Research Site, Athens, 11527, Greece|Research Site, Thessaloniki, 54642, Greece|Research Site, Budapest, 1083, Hungary|Research Site, Szeged, 6720, Hungary|Research Site, Genova, 16147, Italy|Research Site, Napoli, 80129, Italy|Research Site, Torino, 10126, Italy|Research Site, Vilinus, 08406, Lithuania|Research Site, Grafton, Auckland, 1023, New Zealand|Research Site, Krakow, 30-663, Poland|Research Site, Lodz, 93-338, Poland|Research Site, Warszawa, 00-576, Poland|Research Site, Porto, 4050 371, Portugal|Research Site, Moscow, 107014, Russian Federation|Research Site, Saint Petersburg, 198205, Russian Federation|Research Site, Samara, 443095, Russian Federation|Research Site, Kosice, 040 11, Slovakia|Research Site, Barcelona, Cataluña, 08035, Spain|Research Site, Espluques De LLobregat, Cataluña, 08950, Spain|Research Site, Kyiv, 01135, Ukraine
URL: https://clinicaltrials.gov/show/NCT02138838

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress