Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing
NCT ID: NCT01066559
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2010-04-30
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High flux polymethylmetacrylate membrane
High flux polymethylmetacrylate membrane
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
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.
Polysulfone membranes
Polysulfone membrane
Patients be hemodialysed with polysulfone membranes
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.
Interventions
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High flux polymethylmetacrylate membrane
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
Polysulfone membrane
Patients be hemodialysed with polysulfone membranes
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Valérie de PRECIGOUT, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux, France
Pierre BORIES, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse, France
Michel RINCE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Limoges, France
Caroline DELCLAUX, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital, Libourne, France
Antoine POMMEREAU, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic Saint-Augustin, Bordeaux, France
Benjamin DEROURE, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic Delay, Bayonne, France
Hervé BONAREK, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital, Saintes, France
Antoine BENARD, MD
Role: STUDY_CHAIR
University Hospital, Bordeaux, France
Locations
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CH Annonay
Annonay, , France
CH de la côte Basque
Bayonne, , France
CHU de Besançon
Besançon, , France
Saint-Augustin Clinic, Dialyze Unit
Bordeaux, , France
Pellegrin Hospital, Nephrology Unit
Bordeaux, , France
Larrey Hospital, Dialyze Unit
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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CHUBX 2009/11
Identifier Type: -
Identifier Source: org_study_id
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