Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 8, 2016
First Posted Date July 26, 2016
Last Update Posted Date July 26, 2016
Study Start Date November 2008
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2016)
Percentage of regulatory T cells related to atherosclerotic complications events. [ Time Frame: 5 or 10 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 21, 2016)
  • Atherosclerotic complications events [ Time Frame: 5 or 10 years ]
  • Genetic determinants (TNF-alpha, IL-6,...) related to cardiovascular events [ Time Frame: 5 or 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
Official Title Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum Peripheral Blood Mononuclear Cells
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.
Condition Disorder Related to Renal Transplantation
Intervention Other: blood sample
36 ml of blood sample at D0 and 1 year after transplantation
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 21, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2026
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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).

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Didier Ducloux, Pr. dducloux@chu-besancon.fr
Contact: Emilie Gaiffe, Dr. egaiffe@chu-besancon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02843867
Other Study ID Numbers R/2011/44
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators
  • University of Franche-Comté
  • Etablissement Français du Sang
Investigators
Principal Investigator: Didier Ducloux, Pr. CHRU de Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date July 2016