Status:
COMPLETED
FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ph...
Detailed Description
The total length of the study is 14 weeks divided in 2 parts the first part is the screening period she will stay 1 to 2 weeks and the second period with the treatment with permanent dosage during 12 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01220843
Start Date
October 1 2010
End Date
April 1 2013
Last Update
September 19 2025
Active Locations (15)
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1
CHU Amiens service de nephrologie
Amiens, France, 8000
2
CHU de Bordeaux Service de néphrologie
Bordeaux, France, 33076
3
CHU Caen service de néphrologie
Caen, France, 14033
4
CHU Lyon service de néphrologie
Lyon, France, 69437