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

Chronic Renal Failure Clinical Trial

Official 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

Status Completed

Clinical Trial 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.

Clinical Trial 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 weeks.

During the screening visit (Vo) inclusion and non inclusion criteria will be checked and the patient consent will be collected. Biological analysis will be performed.

If the patient still eligible after the reception of biological results, he will be randomized and will received, either sevelamer carbonate, either placebo. The study treatment will be begun at the randomisation visit (V1) the dosage will be 2 tablets 3 times per day (corresponding to 4.8g/d sevelamer carbonate for patient taken active medication).

Patient will be seen every 2 weeks after the first visit (+/-5days) during 6 weeks (visit2/day15, visit3/day30, visit4/day45) and 12 weeks after the randomisation visit (visit5/day90). This visits will include biological analysis, compliance evaluation, adverse events report, concomitant treatments reports.

After the consent signature, all the adverse events will be collected until the end of the study for the patient (Visit5 or end of the study visit). Serious adverse events will be collected until 30 days after the date of the end of the study.

The same dosage of the study treatment will be followed during all the study period except if the phosphatemia (evaluated during one analysis) is found above the normal range planned by the protocol. In this case, the dosage adaptations will be :

• If during a visit the phosphatemia is above or equal to 0.8 mmol/l and superior to 0.5 mmol/l, the study treatment dosage need to be reduce to 2 tablets 3 times per day to 1 tablet 3 times per day.

• If during the next blood punction, the phosphatemia still or equal to 0.8 mmol/l and superior to 0.5 mmol/l, the study treatment will be stopped and a "end of study" visit will be performed.

• If during one study visit, the phosphatemia is above or equal to 0.5 mmol/l,the study treatment will be stopped immediately and a end of study visit will be performed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

• NCT number: NCT01220843
• Study type: Interventional
• Source: Centre Hospitalier Universitaire, Amiens
• Status: Completed
• Phase: Phase 3
• Start date: October 2010
• Completion date: April 2013