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NCT02843867: ORLY-Est

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

Active, enrolled Last updated 3 August 2022
What this trial tests

trial testing blood sample in Disorder Related to Renal Transplantation in 1,150 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
28 November 2008
Primary endpoint
23 October 2020
23 October 2030

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Besancon
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment1,150
Start date28 November 2008
Primary completion23 October 2020
Estimated completion23 October 2030
Sites7 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, any sex, with Disorder Related to Renal Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Getting to the Heart of the Matter: The Role of Regulatory T-Cells (Tregs) in Cardiovascular Disease (CVD) and Atherosclerosis.
    Albany CJ, Trevelin SC, Giganti G, Lombardi G, et al · · 2019 · cited 68× · PMID 31849973 · DOI 10.3389/fimmu.2019.02795
  2. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications.
    Ducloux D, Legendre M, Bamoulid J, Rebibou JM, et al · · 2018 · cited 42× · PMID 30026783 · DOI 10.1186/s12979-018-0121-z
  3. Immune phenotype predicts new onset diabetes after kidney transplantation.
    Ducloux D, Courivaud C, Bamoulid J, Crepin T, et al · · 2019 · cited 5× · PMID 31515130 · DOI 10.1016/j.humimm.2019.08.006
  4. Regulatory T Cells in Atherosclerosis: Is Adoptive Cell Therapy Possible?
    Churov AV, Chegodaev YS, Khotina VA, Ofitserov VP, et al · · 2023 · cited 4× · PMID 37763334 · DOI 10.3390/life13091931
  5. Pre-transplant immune profile defined by principal component analysis predicts acute rejection after kidney transplantation.
    Gaiffe E, Colladant M, Desmaret M, Bamoulid J, et al · · 2023 · cited 1× · PMID 37497224 · DOI 10.3389/fimmu.2023.1192440
  6. A Subset of Pro-inflammatory CXCL10+ LILRB2+ Macrophages Derives From Recipient Monocytes and Drives Renal Allograft Rejection.
    Varin A, Palvair J, Messager L, Bamoulid J, et al · · 2026 · PMID 41517835 · DOI 10.1002/advs.202521294

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