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

April 27, 2016 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Completed

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 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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 8000
        • CHU Amiens service de nephrologie
      • Bordeaux, France, 33076
        • CHU de Bordeaux Service de néphrologie
      • Caen, France, 14033
        • CHU Caen service de néphrologie
      • Lyon, France, 69437
        • CHU Lyon service de néphrologie
      • Marseille, France, 13385
        • CHU Marseille Service de néphrologie
      • Montpellier, France, 34295
        • CHU de Montpellier Hôpital Lapeyronie Service de Néphrologie
      • Nice, France, 06002
        • CHU de Nice Service de néphrologie
      • Paris, France, 75020
        • Hopital Tenon Service de nephrologie
      • Paris, France, 75098
        • Hôpital Européen Georges Pompidou Service de Nephrologie
      • Reims, France, 51092
        • CHU Reims service de néphrologie
      • Saint Ouen, France, 93400
        • Clinique du Landy Centre de dialyse
      • St Etienne, France, 42055
        • CHU St Etienne Hopital Nord Service de néphrologie
      • TASSIN la Demi Lune, France, 69160
        • Néphrologie - Dialyse Centre de Rein Artificiel
      • Valenciennes, France, 59322
        • CH Valenciennes hémodialyse
      • Vandeuvre les Nancy, France, 54511
        • CHU de Nancy service de néphrologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
DOuble blinded, same labels than the active drug same dosage (2 tablets 3 times per day) during the meal
dosage : 2 tablets 3 times per day corresponding taken during meals during 12 weeks
Experimental: Sevelamer carbonate
DOuble blinded, dosage 2 tablets 3 times per day corresponding to 4.8/d to taken during meals
dosage : 2 tablets 3 times per day corresponding taken during meals during 12 weeks ( each tablet :800mg sevelamer carbonate
Other Names:
  • Renvela 800

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 weeks after the beginning of treatment
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 Outcome Measures

Outcome Measure
Time Frame
Evaluation of sevelamer carbonate effect on the serum levels of iPTH
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment
Evaluation of sevelamer carbonate effect on the serum levels of calcitriol (1 25(OH)2D3)
Time Frame: 12 weeks after the beginning of treatment
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)
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment
Evaluation of sevelamer carbonate effect on the urinary levels of phosphate
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment
Evaluation of sevelamer carbonate effect on the urinary levels of calcium
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment
Evaluation of sevelamer carbonate effect on the urinary levels of creatinine
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment
Evaluation of sevelamer carbonate effect on the urinary levels of urea
Time Frame: 12 weeks after the beginning of treatment
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)
Time Frame: 12 weeks after the beginning of treatment
12 weeks after the beginning of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gabriel Choukroun, Ph D, M D, Centre Hospitalier Universitaire, Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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