Disorder Related to Renal TransplantationSIGALNCT02857907
Anti-thymocyte Globulin-induced Immune Senescence
An observational study of Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- Blood sample
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient able to understand the reason of the study
- Signature of informed consent
- Patient who are waiting renal transplant
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Blood sample
- Keywords
- Kidney transplantation, Immunosuppressive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
A blood sample is performed one year after kidney transplantation.
| Study group | Role | What they receive |
|---|---|---|
| ATG group | Patients who received T cell depleting ATG therapy (blood sample one year after transplantation) Receives: Other: Blood sample | |
| anti-CD25 group | Patients who received nondepleting anti-CD25 (blood sample one year after transplantation) Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of senescent lymphocytes
Flow cytometry analysis (7 colors) of lymphocytes
Measured: One year after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startApr 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamal Bamoulid, Doctor, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857907
- Sponsor's protocol ID
- API/2010/15
- Acronym
- SIGAL
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-thymocyte Globulin-induced Immune Senescence
- ClinicalTrials.gov ID
- NCT02857907
- Acronym / sponsor ID
- SIGAL / API/2010/15
- Keywords
- Kidney transplantation, Immunosuppressive treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG group | – | Other: Blood samplePatients who received T cell depleting ATG therapy (blood sample one year after transplantation) |
| anti-CD25 group | – | Other: Blood samplePatients who received nondepleting anti-CD25 (blood sample one year after transplantation) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient able to understand the reason of the study
- Signature of informed consent
- Patient who are waiting renal transplant
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleA blood sample is performed one year after kidney transplantation. | Other | ATG group, anti-CD25 group |
Primary outcome
Percentage of senescent lymphocytes
Time frame: One year after kidney transplantation
Flow cytometry analysis (7 colors) of lymphocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamal Bamoulid, Doctor principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of senescent lymphocytes (time frame: One year after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.