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NCT Number: NCT01066559

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

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Humoral Immune Alterations Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annonay, Annonay, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flux polymethylmetacrylate membrane

Procedure

Patients will be hemodialysed with high flux polymethylmetacrylate membranes

Polysulfone membrane

Procedure

Patients be hemodialysed with polysulfone membranes

Hepatitis B serological control

Biological

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

Seric sCD40 level

Biological

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

Primary outcomes

  1. Percentage of patients who will respond to vaccination

    Time frame: Week 40

Secondary outcomes

  1. Percentage and the level of anti-HBs antibodies

    Time frame: at week 16, week 20, week 24 and week 40

  2. Correlation between the sCD40 levels and the response to HBV vaccination

    Time frame: At week 12 and week 40

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: HEPADIAL

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2010
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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