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

Not Applicable

Completed

• Conditions: Humoral Immune Alterations; Chronic Renal Failure
• Interventions: Procedure: Polysulfone membrane; Procedure: High flux polymethylmetacrylate membrane; Biological: Hepatitis B serological control; Biological: Seric sCD40 level

• Registration Number: NCT01066559
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polysulfone membranes	Hepatitis B serological control	-
Polysulfone membranes	Polysulfone membrane	-
High flux polymethylmetacrylate membrane	Hepatitis B serological control	-
High flux polymethylmetacrylate membrane	High flux polymethylmetacrylate membrane	-
High flux polymethylmetacrylate membrane	Seric sCD40 level	-
Polysulfone membranes	Seric sCD40 level	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients who will respond to vaccination	Week 40

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Larrey Hospital, Dialyze Unit; 🇫🇷 Toulouse, France

CHU de Besançon; 🇫🇷 Besançon, France

Saint-Augustin Clinic, Dialyze Unit; 🇫🇷 Bordeaux, France

Pellegrin Hospital, Nephrology Unit; 🇫🇷 Bordeaux, France

CH de la côte Basque; 🇫🇷 Bayonne, France

CH Annonay; 🇫🇷 Annonay, France