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

Chronic Renal Failure Clinical Trial

— HEPADIAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066559
• Other study ID #: CHUBX 2009/11
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: June 24, 2015
• Start date: April 2010
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Humoral Immune Alterations
• Kidney Failure, Chronic

Intervention

Procedure:
• High flux polymethylmetacrylate membrane
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
• 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
• Seric sCD40 level
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.

Locations

Country	Name	City	State
France	CH Annonay	Annonay
France	CH de la côte Basque	Bayonne
France	CHU de Besançon	Besançon
France	Pellegrin Hospital, Nephrology Unit	Bordeaux
France	Saint-Augustin Clinic, Dialyze Unit	Bordeaux
France	Larrey Hospital, Dialyze Unit	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who will respond to vaccination		Week 40	No
Secondary	Percentage and the level of anti-HBs antibodies		at week 16, week 20, week 24 and week 40	No
Secondary	Correlation between the sCD40 levels and the response to HBV vaccination		At week 12 and week 40	No
Secondary	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	No