Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02857907
  4. Details
NCT02857907 Clinical Trial

Anti-thymocyte Globulin-induced Immune Senescence

Disorder Related to Renal Transplantation Clinical Trial

— SIGAL  

Official title:
Anti-thymocyte Globulin-induced Immune Senescence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02857907
Other study ID # API/2010/15
Secondary ID
Status Completed
Phase N/A
First received August 3, 2016
Last updated August 3, 2016
Start date April 2010
Est. completion date January 2013

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation

Intervention

Other:
• Blood sample
A blood sample is performed one year after kidney transplantation.

Locations
Country Name City State
France University Hospital Besancon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of senescent lymphocytes Flow cytometry analysis (7 colors) of lymphocytes One year after kidney transplantation No
See also
  Status Clinical Trial Phase
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Recruiting NCT02849899 - Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period Phase 3
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Completed NCT00905957 - Transversus Abdominis Plane Block For Renal Transplant Recipients N/A
Active, not recruiting NCT02843867 - Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
Active, not recruiting NCT02751099 - Bone and Cardiovascular Disease After Kidney Transplant
Completed NCT01744067 - The Effects of Omega-3 Fatty Acids in Renal Transplantation Phase 4
Completed NCT01646099 - Sun Protection of Kidney Transplant Recipients N/A
Active, not recruiting NCT03935958 - Curcumin in Kidney Transplant Recipients N/A
Recruiting NCT02513602 - Osseointegrated Dental Implants in Kidney Transplanted Patients N/A
Completed NCT01844713 - Evaluation of Sun Protection Education for Kidney Transplant Recipients N/A
Recruiting NCT01550445 - Steroid Withdrawal Immunosuppression After Renal Transplantation Phase 4
Completed NCT02540395 - Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation N/A
Completed NCT01195194 - Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity. Phase 4
Completed NCT00724022 - Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation Phase 4
Terminated NCT00167661 - Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation Phase 1/Phase 2
Completed NCT03968588 - Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation Phase 4
Recruiting NCT02515643 - Contribution of Renal Function to Endothelial Dysfunction in Living Kidney Donors and Transplant Recipients N/A
Completed NCT00455013 - A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation Phase 2