Ignite Creation Date:
2024-05-05 @ 10:15 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01066559
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2010-02-09
Brief Title:
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane Correlation to Soluble CD40 Clearing
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPADIAL
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 CD40CD154 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None