Chronic Renal Failure Clinical Trial
— FRENCHOfficial title:
Randomized Placebo Controlled Double-blind Trial in CKD Patients Not on Dialysis to Evaluate the Effect of Sevelamer Carbonate in the Control of FGF-23 Serum Levels and Its Consequences in the Evolution of PTH, Calcitriol and Mineral Metabolism Parameters Levels
The purpose of this study is to evaluate in Chronic Kidney Disease (CKD) patients not on dialysis and who have an Fibroblast growth factor 23 (FGF23) serum levels elevated, the effect of non calcic phosphate binder: sevelamer carbonate. This treatment could lead to a diminution of FGF23 serum levels due to the diminution of intestinal absorption of dietary phosphate. In addition, the investigators will describe the impact of the FGF23 level monitoring on the main phosphocalcium metabolism markers as phosphatemia, intact parathyroid hormone (iPTH), serum calcitriol and phosphaturia.
Status | Completed |
Enrollment | 98 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who gave their written consent - Women or men over 18 years - No concomitant treatment with phosphate binders - CKD patients not on dialysis stage 3b or 4, as a GFR (glomerular filtration rate) between 15 and 45 ml/min/1.73m2, using simplified MDRD formula - At the inclusion visit,patients with blood results as levels of C-terminal FGF-23 > 120 rU/ml and fasting phosphatemia > 1.0 mmol/l - Able to comply with the study procedures during all the study period - Willing to abstain from taking any following medication during all the study period :antiacid and phosphate binders with aluminium, magnesium, calcium or lanthanum;Treatment for hyperparathyroid : active vitamin D and calcimimetic ; native vitamin D - Female subjects who are of childbearing potential must have a reliable contraceptive methods during all the study period (hormonal, barrier methods or intrauterine device) - No Participation in any clinical trial using an investigational product or device during the 30 days preceding the first protocol visit - Informed patient who agreed with the utilisation of his data for the study - Able to read and understand french and study objectives - Inscription to medical assurance Exclusion Criteria: - predisposition with or presence of intestinal or ileus obstruction or severe gastrointestinal motility disorder(like severe constipation) - Antecedent of major gastrointestinal surgery - Abusive consumption of alcohol and drug (exclude tabacco) according the investigator - Arrythmia treated by antiarrythmic agent or epilepsia treated by anticonvulsant - Antecedent of kidney transplantation - Antecedent of parathyroidectomy - At the inclusion visit,patients with blood results as fasting phosphatemia > 1.78 mmol/l or serum 25(OH)D3< 20 ng/ml (<50 nmol/) - Pregnancy or breastfeeding |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens service de nephrologie | Amiens | |
France | CHU de Bordeaux Service de néphrologie | Bordeaux | |
France | CHU Caen service de néphrologie | Caen | |
France | CHU Lyon service de néphrologie | Lyon | |
France | CHU Marseille Service de néphrologie | Marseille | |
France | CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie | Montpellier | |
France | CHU de Nice Service de néphrologie | Nice | |
France | Hôpital Européen Georges Pompidou Service de Nephrologie | Paris | |
France | Hôpital Tenon Service de Nephrologie | Paris | |
France | CHU Reims service de néphrologie | Reims | |
France | Clinique du Landy Centre de dialyse | Saint Ouen | |
France | CHU St Etienne Hopital Nord Service de néphrologie | St Etienne | |
France | Néphrologie - Dialyse Centre de Rein Artificiel | TASSIN la Demi Lune | |
France | CH Valenciennes hémodialyse | Valenciennes | |
France | CHU de Nancy service de néphrologie | Vandeuvre les Nancy |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens | Genzyme, a Sanofi Company |
France,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | No |
Secondary | Evaluation of sevelamer carbonate effect on the serum levels of iPTH | 12 weeks after the beginning of treatment | No | |
Secondary | Evaluation of sevelamer carbonate effect on the serum levels of calcitriol (1 25(OH)2D3) | 12 weeks after the beginning of treatment | No | |
Secondary | 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 | No | |
Secondary | Evaluation of sevelamer carbonate effect on the urinary levels of phosphate | 12 weeks after the beginning of treatment | No | |
Secondary | Evaluation of sevelamer carbonate effect on the urinary levels of calcium | 12 weeks after the beginning of treatment | No | |
Secondary | Evaluation of sevelamer carbonate effect on the urinary levels of creatinine | 12 weeks after the beginning of treatment | No | |
Secondary | Evaluation of sevelamer carbonate effect on the urinary levels of urea | 12 weeks after the beginning of treatment | No | |
Secondary | 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 | No |
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