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ACTIVE NOT RECRUITING
NCT02843867

Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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.

Official title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1150

Start Date

2008-11-28

Completion Date

2030-10-23

Last Updated

2022-08-03

Healthy Volunteers

No

Interventions

OTHER

blood sample

36 ml of blood sample at D0 and 1 year after transplantation

Locations (7)

CHU de Besançon

Besançon, France

CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand

Clermont-Ferrand, France

CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex

Dijon, France

Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex

Le Kremlin-Bicêtre, France

CHU Brabois, et Vandoeuvre les Nancy

Nancy, France

CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex

Reims, France

Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex

Strasbourg, France