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CompletedNCT02857907SIGALUpdated Aug 5, 2016

Anti-thymocyte Globulin-induced Immune Senescence

An observational study in Disorder Related to Renal Transplantation, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
97
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Disorder Related to Renal Transplantation

Keywords

  • Kidney transplantation
  • Immunosuppressive treatment
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In context

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • ATG group

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

    Other: Blood sample

  • anti-CD25 group

    Patients who received nondepleting anti-CD25 (blood sample one year after transplantation)

    Other: Blood sample

Interventions

  • OtherBlood sample

    A blood sample is performed one year after kidney transplantation.

06

What researchers measure

Primary outcomes

  1. Percentage of senescent lymphocytes

    Flow cytometry analysis (7 colors) of lymphocytes

    Time frame: One year after kidney transplantation

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Study locations

1 site
  • University Hospital
    Besancon, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02857907
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
Apr 2010
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Aug 5, 2016

Study contacts

Jamal Bamoulid, Doctor
principal investigator · CHU Besançon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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