FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Sevelamer

Criteria

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