NCT02857907

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

August 3, 2016

Last Update Submit

August 3, 2016

Conditions

Keywords

Kidney transplantationImmunosuppressive treatment

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)

Other: Blood sample

anti-CD25 group

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

Other: Blood sample

Interventions

A blood sample is performed one year after kidney transplantation.

ATG groupanti-CD25 group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral Blood Mononuclear Cells

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jamal Bamoulid, Doctor

    CHU Besançon

    PRINCIPAL INVESTIGATOR

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

Locations