Trial | NCT01066559  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    27
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
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 Started
Apr 30
2010
Primary Completion
Jan 31
2015
Study Completion
Jan 31
2015
Last Update
Jun 25
2015
Estimate

Procedure High flux polymethylmetacrylate membrane

Patients will be hemodialysed with high flux polymethylmetacrylate membranes

Procedure Polysulfone membrane

Patients be hemodialysed with 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.

High flux polymethylmetacrylate membrane Experimental

Polysulfone membranes Active Comparator

Criteria 

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
No Results Posted