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Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation (ORLY-Est)

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ClinicalTrials.gov Identifier: NCT02843867
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
University of Franche-Comté
Etablissement Français du Sang
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment
Disorder Related to Renal Transplantation Other: blood sample

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)
Study Start Date : November 2008
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Percentage of regulatory T cells related to atherosclerotic complications events. [ Time Frame: 5 or 10 years ]

Secondary Outcome Measures :
  1. Atherosclerotic complications events [ Time Frame: 5 or 10 years ]
  2. Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events [ Time Frame: 5 or 10 years ]

Biospecimen Retention:   Samples Without DNA
Serum Peripheral Blood Mononuclear Cells


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population corresponds to 1000 patients receiving a renal transplant in Hospital of Besançon, Dijon, Nancy, Reims, Clermont-Ferrand, Strasbourg et Kremlin-Bicêtre.
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843867


Contacts
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Contact: Didier Ducloux, Pr. dducloux@chu-besancon.fr
Contact: Emilie Gaiffe, Dr. egaiffe@chu-besancon.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Didier Ducloux, Pr.         
CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Detex, Pr.         
CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex Recruiting
Dijon, France, 21079
Contact: Christiane Mousson, Pr.         
Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Antoine Durrbach, Pr.         
CHU Brabois, et Vandoeuvre les Nancy Active, not recruiting
Nancy, France
CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex Active, not recruiting
Reims, France, 51092
Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex Active, not recruiting
Strasbourg, France, 67091
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
University of Franche-Comté
Etablissement Français du Sang
Investigators
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Principal Investigator: Didier Ducloux, Pr. CHRU de Besançon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02843867    
Other Study ID Numbers: R/2011/44
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Identified individual participant data for all outcome measures will be made available within 6 monts of study completion
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Transplantation
Immunology
Atherosclerosis