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

Primary Purpose

Chronic Renal Failure, Humoral Immune Alterations

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

High flux polymethylmetacrylate membrane

Polysulfone membrane

Hepatitis B serological control

Seric sCD40 level

About this trial

This is an interventional treatment trial for Chronic Renal Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CH Annonay
CH de la côte Basque
CHU de Besançon
Saint-Augustin Clinic, Dialyze Unit
Pellegrin Hospital, Nephrology Unit
Larrey Hospital, Dialyze Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flux polymethylmetacrylate membrane

Polysulfone membranes

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients who will respond to vaccination

Secondary Outcome Measures

Percentage and the level of anti-HBs antibodies

Correlation between the sCD40 levels and the response to HBV vaccination

Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.

Full Information

NCT ID

NCT01066559

First Posted

February 9, 2010

Last Updated

June 24, 2015

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT01066559

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure, Humoral Immune Alterations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High flux polymethylmetacrylate membrane

Arm Type

Experimental

Arm Title

Polysulfone membranes

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

High flux polymethylmetacrylate membrane

Intervention Description

Patients will be hemodialysed with high flux polymethylmetacrylate membranes

Intervention Type

Procedure

Intervention Name(s)

Polysulfone membrane

Intervention Description

Patients be hemodialysed with polysulfone membranes

Intervention Type

Biological

Intervention Name(s)

Hepatitis B serological control

Intervention Description

It will be assessed at week 16, week 20 and week 40

Intervention Type

Biological

Intervention Name(s)

Seric sCD40 level

Intervention Description

Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.

Primary Outcome Measure Information:

Title

Percentage of patients who will respond to vaccination

Time Frame

Week 40

Secondary Outcome Measure Information:

Title

Percentage and the level of anti-HBs antibodies

Time Frame

at week 16, week 20, week 24 and week 40

Title

Correlation between the sCD40 levels and the response to HBV vaccination

Time Frame

At week 12 and week 40

Title

Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.

Time Frame

at week 12, week 24, and week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials: