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Completed

NCT Number: NCT02857907

Anti-thymocyte Globulin-induced Immune Senescence

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.

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Key information

Conditions

Disorder Related to Renal Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Besançon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

A blood sample is performed one year after kidney transplantation.

Primary outcomes

  1. Percentage of senescent lymphocytes

    Time frame: One year after kidney transplantation

    Flow cytometry analysis (7 colors) of lymphocytes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: SIGAL

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2016
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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