Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01109186
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2010-04-21
Brief Title:
Anti-BK Virus Immune Response and Kidney Transplantation
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Role of Specific Immune Cellular Response in the Control of BK Virus Infection Prospective Study Monocentric and Longitudinal During the First Nine Months After a Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2021-09
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:
BKv
Brief Summary:
BK virus infections are very frequent during months following a kidney transplantation a viral reactivation is observed for almost 50 of patients during first year This reactivation leads to a viremia for 10 to 15 of patient during this same period The most frequent complication is interstitial nephritis for 2 to 8 of patients 27 patients representing 27 during 6 years in Nantes
An intensive et persisting viral replication assessed by detection of high blood viral load could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft
Biological follow-up of these infections lay on the measures of viral load Their positivity must alert the physician and lead him to modulate immunosuppressive treatment
Actually there is no real consensus about the modalities of pharmacological immunosuppression decrease decrease dose or change of molecule
Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove
weakness of immune cellular response for patient with high viremia
increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion
New prospective and longitudinal data comparing the immune cellular response systematic and early after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history
The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control Furthermore the investigators propose to identify better diagnostic and prognostic makers
An intensive et persisting viral replication assessed by detection of high blood viral load could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft
Biological follow-up of these infections lay on the measures of viral load Their positivity must alert the physician and lead him to modulate immunosuppressive treatment
Actually there is no real consensus about the modalities of pharmacological immunosuppression decrease decrease dose or change of molecule
Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove
weakness of immune cellular response for patient with high viremia
increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion
New prospective and longitudinal data comparing the immune cellular response systematic and early after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history
The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control Furthermore the investigators propose to identify better diagnostic and prognostic makers
Detailed Description:
None
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