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

Disorder Related to Renal Transplantation Clinical Trial

— ORLY-Est  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02843867
• Other study ID #: R/2011/44
• Status: Active, not recruiting
• 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
• 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).

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