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

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01066559
First received: February 9, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Chronic Renal Failure
Humoral Immune Alterations
Procedure: High flux polymethylmetacrylate membrane
Procedure: Polysulfone membrane
Biological: Hepatitis B serological control
Biological: Seric sCD40 level

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Randomized Clinical 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Percentage of patients who will respond to vaccination [ Time Frame: Week 40 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage and the level of anti-HBs antibodies [ Time Frame: at week 16, week 20, week 24 and week 40 ] [ Designated as safety issue: No ]
  • Correlation between the sCD40 levels and the response to HBV vaccination [ Time Frame: At week 12 and week 40 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High flux polymethylmetacrylate membrane Procedure: High flux polymethylmetacrylate membrane
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
Biological: Hepatitis B serological control
It will be assessed at week 16, week 20 and week 40
Biological: Seric sCD40 level
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
Active Comparator: Polysulfone membranes Procedure: 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
Biological: Seric sCD40 level
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066559

Contacts
Contact: Valérie de PRECIGOUT, MD +33556795679 valerie.deprecigout@chu-bordeaux.fr

Locations
France
CH Annonay Recruiting
Annonay, France
Contact: Carole Deprele, Dr         
Principal Investigator: Carole Deprele, Dr         
Sub-Investigator: Eric Legrand, Dr         
Sub-Investigator: Jean-Michel Marc, Dr         
Sub-Investigator: Ioana Metes, Dr         
Delay Clinic, Dialyze Unit Recruiting
Bayonne, France, 64100
Contact: Benjamin DEROURE, MD       deroure@clinique-delay.fr   
Sub-Investigator: Marie-Cécile CAZIN, MD         
Principal Investigator: Benjamin CAZIN, MD         
Pellegrin Hospital, Nephrology Unit Recruiting
Bordeaux, France, 33076
Contact: Valérie de PRECIGOUT, MD    +33556795679    valerie.deprecigout@chu-bordeaux.fr   
Sub-Investigator: Yahsou DELMAS, MD         
Sub-Investigator: Philippe CHAUVEAU, MD         
Principal Investigator: Valérie de PRECIGOUT, MD         
Saint-Augustin Clinic, Dialyze Unit Recruiting
Bordeaux, France, 33000
Contact: Antoine POMMEREAU, MD       a.pommereau@free.fr   
Principal Investigator: Antoine POMMEREAU, MD         
Robert Hospital, Dialyze Unit Recruiting
Libourne, France, 33500
Contact: Caroline DELCLAUX, MD       caroline.delclaux@ch-libourne.fr   
Principal Investigator: Caroline DELCLAUX, MD         
Dupuytren Hospital, Dialyze Unit Not yet recruiting
Limoges, France, 87042
Contact: Michel RINCE, MD       michel.rince@chu-limoges.fr   
Principal Investigator: Michel RINCE, MD         
Saintonge Hospital, Dialyze Unit Recruiting
Saintes, France, 17100
Contact: Hervé BONAREK, MD         
Principal Investigator: Hervé BONAREK, MD         
Larrey Hospital, Dialyze Unit Not yet recruiting
Toulouse, France, 31059
Contact: Pierre BORIES, MD       bories.p@chu-toulouse.fr   
Principal Investigator: Pierre BORIES, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Valérie de PRECIGOUT, MD University Hospital, Bordeaux, France
Principal Investigator: Pierre BORIES, MD University Hospital, Toulouse, France
Principal Investigator: Michel RINCE, MD University Hospital, Limoges, France
Principal Investigator: Caroline DELCLAUX, MD Hospital, Libourne, France
Principal Investigator: Antoine POMMEREAU, MD Clinic Saint-Augustin, Bordeaux, France
Principal Investigator: Benjamin DEROURE, MD Clinic Delay, Bayonne, France
Principal Investigator: Hervé BONAREK, MD Hospital, Saintes, France
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01066559     History of Changes
Other Study ID Numbers: CHUBX 2009/11
Study First Received: February 9, 2010
Last Updated: November 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 20, 2014