Anti-thymocyte Globulin-induced Immune Senescence (SIGAL)

August 3, 2016 updated by: Centre Hospitalier Universitaire de Besancon
The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune senescence. Markers of immune senescence expression is assessed in a prospective cohort of renal transplant recipients the day of transplantation and one year after renal transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The anti-thymocyte globulin (ATG) are used in the prevention and treatment of acute rejection in organ transplantation. They are at the origin of a brutal CD4 lymphocyte depletion followed by a gradual recovery of the lymphocyte pool. Nevertheless, CD4 lymphopenia can persist in some patients.

SIGAL study aims to characterize the immune responses of lymphopenic patients (after administration of ATG) in order to identify possible similarities with immunosenescence.The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients awaiting kidney transplantation, followed at Besançon University Hospital and who have given their consent for the conservation of cells for a study of the immune system in kidney transplant patients.

Description

Inclusion Criteria:

  • Patient able to understand the reason of the study
  • Signature of informed consent
  • Patient who are waiting renal transplant

Exclusion Criteria:

  • Inability to understand the reasons for the study; psychiatric disorders
  • Any history in the last 2 years of immunosuppressive therapy (except steroids)
  • History of cancer (except skin cancer) or treated hematological malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ATG group
Patients who received T cell depleting ATG therapy (blood sample one year after transplantation)
Other: Blood sample
A blood sample is performed one year after kidney transplantation.
anti-CD25 group
Patients who received nondepleting anti-CD25 (blood sample one year after transplantation)
Other: Blood sample
A blood sample is performed one year after kidney transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of senescent lymphocytes
Time Frame: One year after kidney transplantation
Flow cytometry analysis (7 colors) of lymphocytes
One year after kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Jamal Bamoulid, Doctor, CHU Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • API/2010/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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