Clinical trial NCT01066559: Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Humoral Immune Alterations
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients who will respond to vaccination
timeFrame: Week 40
Secondary outcomes:
measure: Percentage and the level of anti-HBs antibodies
timeFrame: at week 16, week 20, week 24 and week 40
measure: Correlation between the sCD40 levels and the response to HBV vaccination
timeFrame: At week 12 and week 40
measure: Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.
timeFrame: at week 12, week 24, and week 36
Other outcomes:
Locations:
city: Annonay
country: France
facility: CH Annonay
city: Bayonne
country: France
facility: CH de la côte Basque
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: Saint-Augustin Clinic, Dialyze Unit
city: Bordeaux
country: France
facility: Pellegrin Hospital, Nephrology Unit
city: Toulouse
country: France
facility: Larrey Hospital, Dialyze Unit
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Valérie de PRECIGOUT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse, France
name: Pierre BORIES, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Limoges, France
name: Michel RINCE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital, Libourne, France
name: Caroline DELCLAUX, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic Saint-Augustin, Bordeaux, France
name: Antoine POMMEREAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic Delay, Bayonne, France
name: Benjamin DEROURE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital, Saintes, France
name: Hervé BONAREK, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux, France
name: Antoine BENARD, MD
role: STUDY_CHAIR
References:
citation: de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.