Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02843867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-08-03
First Post:
2016-07-08
Brief Title:
Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Influence de lORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale étude ORLY-EST 2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-07
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:
ORLY-Est
Brief Summary:
The incidence of atherosclerotic complications is increased after kidney transplantation Traditional risk factors do not fully explain this increased risk Atherosclerosis is an inflammatory disease in which all players in the immune response are involved The impact of these immune responses is not well known in immunocompromised patients particularly among organ transplant Nevertheless the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation
The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation
Since November 2008 the investigators began a multicenter prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion It was planned to include 500 patients and to date a little more than half have been included After completion of the blood test the tubes are routed over the Biomonitoring Platform CIC-BT 506 Besançon and the samples are stored in CRB Dijon
The atherosclerotic events are recorded prospectively The investigators hope to implement as part of ORLY IS a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events
Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5 of atherosclerotic complications
The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation
Since November 2008 the investigators began a multicenter prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion It was planned to include 500 patients and to date a little more than half have been included After completion of the blood test the tubes are routed over the Biomonitoring Platform CIC-BT 506 Besançon and the samples are stored in CRB Dijon
The atherosclerotic events are recorded prospectively The investigators hope to implement as part of ORLY IS a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events
Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5 of atherosclerotic complications
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