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Clinical Trial Details

Trial ID: L0418
Source ID: NCT01574326
Associated Drug: Placebo
Title: An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01574326/results
Conditions: Hyperphosphatemia|Chronic Kidney Disease
Interventions: DRUG: Placebo|DRUG: Sevelamer carbonate
Outcome Measures: Primary: Change From Baseline (Week 0) to Week 2 in Serum Phosphorus, Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated., Baseline, Week 2|Treatment - Emergent Adverse Events (AEs), A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected., Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP) | Secondary: Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus, Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated., Baseline, Week 28/Early Termination
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 101
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-05
Completion Date: 2015-06
Results First Posted: 2016-07-25
Last Update Posted: 2016-07-25
Locations: Investigational Site Number 8003, Birmingham, Alabama, 35205, United States|Investigational Site Number 8005, Birmingham, Alabama, 35205, United States|Investigational Site Number 8013, Los Angeles, California, 90024, United States|Investigational Site Number 8014, San Francisco, California, 94143, United States|Investigational Site Number 8025, Orlando, Florida, 32806, United States|Investigational Site Number 8007, Atlanta, Georgia, 30322, United States|Investigational Site Number 8019, Iowa City, Iowa, United States|Investigational Site Number 8012, Baltimore, Maryland, 21287, United States|Investigational Site Number 8008, Boston, Massachusetts, 02115, United States|Investigational Site Number 8020, Detroit, Michigan, 48201, United States|Investigational Site Number 8022, Kansas City, Missouri, 64108, United States|Investigational Site Number 8023, St Louis, Missouri, 63110, United States|Investigational Site Number 8017, Livingston, New Jersey, 07039, United States|Investigational Site Number 8018, Buffalo, New York, 14222, United States|Investigational Site Number 8009, Greenville, North Carolina, 27834, United States|Investigational Site Number 8010, Portland, Oregon, 97201-3098, United States|Investigational Site Number 8011, Philadelphia, Pennsylvania, 19104, United States|Investigational Site Number 8026, Dallas, Texas, 75390, United States|Investigational Site Number 8016, Houston, Texas, 77030, United States|Investigational Site Number 8001, San Antonio, Texas, 78229, United States|Investigational Site Number 8002, Charlottesville, Virginia, 22908, United States|Investigational Site Number 8027, Richmond, Virginia, 23298-0034, United States|Investigational Site Number 8006, Seattle, Washington, 98105, United States|Investigational Site Number 8101, Bordeaux, 33076, France|Investigational Site Number 8102, Bron, 69677, France|Investigational Site Number 8103, Paris Cedex 19, 75935, France|Investigational Site Number 8201, Berlin, 13353, Germany|Investigational Site Number 8202, Marburg, 35033, Germany|Investigational Site Number 8302, Kaunas, 50009, Lithuania|Investigational Site Number 8301, Vilnius, 08406, Lithuania|Investigational Site Number 8402, Gdansk, Poland|Investigational Site Number 8401, Krakow, 301-663, Poland
URL: https://clinicaltrials.gov/show/NCT01574326

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress