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

NCT02843867 | Active Not Recruiting

• 1 other identifier: R/2011/44
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 7

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.

Conditions

Disorder Related to Renal Transplantation

Keywords

Transplantation; Immunology; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of regulatory T cells related to atherosclerotic complications events.

  Percentage of regulatory T cells

  5 or 10 years

Secondary Outcomes (2)

• Atherosclerotic complications events

  5 or 10 years

• Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events

  5 or 10 years

Interventions

blood sample OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female patients aged over 18 years
• Patients receiving a renal transplant
• Patients able to understand the benefits and risks of testing
• Patients gave written informed consent.

You may not qualify if:

• Immunosuppressive therapy immediately prior to transplantation
• Cancer (except skin cancer) or malignant blood disease being treated; active infection; decompensated cirrhosis \[patients had cancer and considered as cured or in remission, patients with virus infection of hepatitis B or hepatitis C and having no cirrhosis may be included\].

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• University of Franche-Comté: collaborator
• Etablissement Français du Sang: collaborator

Study Sites (7)

CHU de Besançon

Besançon, 25000, France

Location

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

Clermont-Ferrand, 63003, France

Location

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

Dijon, 21079, France

Location

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

Le Kremlin-Bicêtre, 94275, France

Location

CHU Brabois, et Vandoeuvre les Nancy

Nancy, France

Location

CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex

Reims, 51092, France

Location

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

Strasbourg, 67091, France

Location

Related Publications (2)

• Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.

  PMID: 31515130 DERIVED

• Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.

  PMID: 30026783 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Peripheral Blood Mononuclear Cells

MeSH Terms

Conditions

Atherosclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Didier Ducloux, Pr.

  CHRU de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 26, 2016
• Study Start: November 28, 2008
• Primary Completion: October 23, 2020
• Study Completion (Estimated): October 23, 2030
• Last Updated: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (7)