Chronic Renal Failure Clinical Trial
Official title:
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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