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Clinical Trial Details

Trial ID: L0093
Source ID: NCT01220843
Associated Drug: Placebo
Title: FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
Acronym: FRENCH
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Renal Failure
Interventions: DRUG: Placebo|DRUG: Sevelamer carbonate
Outcome Measures: Primary: Measurement of the serum levels of C terminal segment of fibroblast growth factor 23 (FGF23) and evaluation of sevelamer carbonate effect on this levels in comparison with placebo, Indeed the sevelamer carbonate could lead to a diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary phosphate., 12 weeks after the beginning of treatment | Secondary: Evaluation of sevelamer carbonate effect on the serum levels of iPTH, 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the serum levels of calcitriol (1 25(OH)2D3), 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the serum levels of others mineral metabolism parameters (phosphore, calcium, intact FGF-23 , 25(OH)D3, bone specific alkaline phosphatases, osteocalcin, collagen crosslink, C reactive protein), 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the urinary levels of phosphate, 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the urinary levels of calcium, 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the urinary levels of creatinine, 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the urinary levels of urea, 12 weeks after the beginning of treatment|Evaluation of sevelamer carbonate effect on the serum and urinary levels of specific biomarkers (serum : fetuin A, para-cresyl sulfate, osteopontin), 12 weeks after the beginning of treatment
Sponsor/Collaborators: Sponsor: Centre Hospitalier Universitaire, Amiens | Collaborators: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 98
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2013-04
Results First Posted:
Last Update Posted: 2016-04-28
Locations: CHU Amiens service de nephrologie, Amiens, 8000, France|CHU de Bordeaux Service de néphrologie, Bordeaux, 33076, France|CHU Caen service de néphrologie, Caen, 14033, France|CHU Lyon service de néphrologie, Lyon, 69437, France|CHU Marseille Service de néphrologie, Marseille, 13385, France|CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie, Montpellier, 34295, France|CHU de Nice Service de néphrologie, Nice, 06002, France|Hôpital Tenon Service de Nephrologie, Paris, 75020, France|Hôpital Européen Georges Pompidou Service de Nephrologie, Paris, 75098, France|CHU Reims service de néphrologie, Reims, 51092, France|Clinique du Landy Centre de dialyse, Saint Ouen, 93400, France|CHU St Etienne Hopital Nord Service de néphrologie, St Etienne, 42055, France|Néphrologie - Dialyse Centre de Rein Artificiel, TASSIN la Demi Lune, 69160, France|CH Valenciennes hémodialyse, Valenciennes, 59322, France|CHU de Nancy service de néphrologie, Vandeuvre les Nancy, 54511, France
URL: https://clinicaltrials.gov/show/NCT01220843

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress