Anti-thymocyte Globulin-induced Immune Senescence

Completed

• Conditions: Disorder Related to Renal Transplantation
• Interventions: Other: Blood sample

• Registration Number: NCT02857907
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-05
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anti-CD25 group	Blood sample	Patients who received nondepleting anti-CD25 (blood sample one year after transplantation)
ATG group	Blood sample	Patients who received T cell depleting ATG therapy (blood sample one year after transplantation)

Primary Outcome Measures

Name	Time	Method
Percentage of senescent lymphocytes	One year after kidney transplantation	Flow cytometry analysis (7 colors) of lymphocytes

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Besancon, France