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Anti-thymocyte Globulin-induced Immune Senescence (SIGAL)

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Disorder Related to Renal Transplantation

Treatments

Other: Blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT02857907
API/2010/15

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

97 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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