Anti-thymocyte Globulin-induced Immune Senescence

NCT ID: NCT02857907

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Disorder Related to Renal Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ATG group

Patients who received T cell depleting ATG therapy (blood sample one year after transplantation)

Blood sample

Intervention Type OTHER

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)

Blood sample

Intervention Type OTHER

A blood sample is performed one year after kidney transplantation.

Interventions

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Blood sample

A blood sample is performed one year after kidney transplantation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamal Bamoulid, Doctor

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

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University Hospital

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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API/2010/15

Identifier Type: -

Identifier Source: org_study_id

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