Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing (HEPADIAL)

June 24, 2015 updated by: University Hospital, Bordeaux

Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing

The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.

The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

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

  • France
      • Annonay, France
        • Ch Annonay
      • Bayonne, France, 64100
        • CH de la Cote Basque
      • Besançon, France, 25000
        • CHU de Besancon
      • Bordeaux, France, 33000
        • Saint-Augustin Clinic, Dialyze Unit
      • Bordeaux, France, 33076
        • Pellegrin Hospital, Nephrology Unit
      • Toulouse, France, 31059
        • Larrey Hospital, Dialyze Unit

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years, male or female
  • Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
  • Hemodialyzed patients with hemodialysed sessions performed three times a week
  • Patient able to give informed consent and affiliated to the medical insurance

Exclusion Criteria:

  • Pregnant woman
  • Patient never vaccinated against HBV
  • Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
  • Active neoplasia or plasma cell dyscrasia
  • VIH infection
  • Known allergy to vaccine or to PMMA membrane
  • Patient dialysed with PMMA membrane within three months before screening
  • Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration
  • Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.
  • Patient under judicial protection

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flux polymethylmetacrylate membrane
Procedure: High flux polymethylmetacrylate membrane
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
Biological: Hepatitis B serological control
It will be assessed at week 16, week 20 and week 40
Biological: Seric sCD40 level
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
Active Comparator: Polysulfone membranes
Biological: Hepatitis B serological control
It will be assessed at week 16, week 20 and week 40
Biological: Seric sCD40 level
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
Procedure: Polysulfone membrane
Patients be hemodialysed with polysulfone membranes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who will respond to vaccination
Time Frame: Week 40
Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage and the level of anti-HBs antibodies
Time Frame: at week 16, week 20, week 24 and week 40
at week 16, week 20, week 24 and week 40
Correlation between the sCD40 levels and the response to HBV vaccination
Time Frame: At week 12 and week 40
At week 12 and week 40
Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.
Time Frame: at week 12, week 24, and week 36
at week 12, week 24, and week 36

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Antoine BENARD, MD, University Hospital, Bordeaux, France
  • Principal Investigator: Valérie de PRECIGOUT, MD, University Hospital, Bordeaux, France
  • Principal Investigator: Pierre BORIES, MD, University Hospital, Toulouse, France
  • Principal Investigator: Michel RINCE, MD, University Hospital, Limoges, France
  • Principal Investigator: Caroline DELCLAUX, MD, Hospital, Libourne, France
  • Principal Investigator: Antoine POMMEREAU, MD, Clinic Saint-Augustin, Bordeaux, France
  • Principal Investigator: Benjamin DEROURE, MD, Clinic Delay, Bayonne, France
  • Principal Investigator: Hervé BONAREK, MD, Hospital, Saintes, France

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

April 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2009/11

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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