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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02843867
Other study ID # R/2011/44
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 28, 2008
Est. completion date October 23, 2030

Study information

Verified date July 2022
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1150
Est. completion date October 23, 2030
Est. primary completion date October 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female patients aged over 18 years 2. Patients receiving a renal transplant 3. Patients able to understand the benefits and risks of testing 4. Patients gave written informed consent. Exclusion Criteria: 1. Inability to understand the advantages and disadvantages of the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study. 2. Immunosuppressive therapy immediately prior to transplantation 3. Cancer (except skin cancer) or malignant blood disease being treated; active infection; decompensated cirrhosis [patients had cancer and considered as cured or in remission, patients with virus infection of hepatitis B or hepatitis C and having no cirrhosis may be included]. This study is strictly non-interventional, participation in another study is not a cons-indication to the inclusion in this study and no exclusion period is required for inclusion in another study after inclusion in this study (Art L. 1121-12 (loi n°2004-806 du 9 Août 2004).

Study Design


Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation

Intervention

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

Locations

Country Name City State
France 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

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon Etablissement Français du Sang, University of Franche-Comté

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of regulatory T cells related to atherosclerotic complications events. Percentage of regulatory T cells 5 or 10 years
Secondary Atherosclerotic complications events Percentage of regulatory T cells 5 or 10 years
Secondary Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events Percentage of regulatory T cells 5 or 10 years
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