Anti-thymocyte Globulin-induced Immune Senescence
SIGAL
1 other identifier
observational
97
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedAugust 5, 2016
August 1, 2016
2.8 years
August 3, 2016
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of senescent lymphocytes
Flow cytometry analysis (7 colors) of lymphocytes
One year after kidney transplantation
Study Arms (2)
ATG group
Patients who received T cell depleting ATG therapy (blood sample one year after transplantation)
anti-CD25 group
Patients who received nondepleting anti-CD25 (blood sample one year after transplantation)
Interventions
A blood sample is performed one year after kidney transplantation.
Eligibility Criteria
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.
You may qualify if:
- Patient able to understand the reason of the study
- Signature of informed consent
- Patient who are waiting renal transplant
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Besançon, France
Biospecimen
Peripheral Blood Mononuclear Cells
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamal Bamoulid, Doctor
CHU Besançon
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 5, 2016
Study Start
April 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
August 5, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share