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Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation (ECLAT)

Primary Purpose

End-stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for End-stage Renal Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 and under 70 years old
  • Patients in care for a first priority renal transplant.
  • Patients with low immunological risk
  • Patients with prior written informed consent

Exclusion Criteria:

  • Poor understanding of the French language
  • Pregnant, breastfeeding or partying women
  • Persons deprived of liberty by an administrative or judicial decision
  • Persons undergoing psychiatric care under duress
  • Adults who are subject to a legal or non-state protection measure to express their consent

Sites / Locations

  • Dr Anne-Sophie GARNIERRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient in need of a kidney transplant

Arm Description

Outcomes

Primary Outcome Measures

Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy

Secondary Outcome Measures

Rate of CD45RC for patient with acute rejection suspicion
acute rejection confirmed or not
Rate of CD45RC on circulating T lymphocytes
Evolution of the expression of CD45RC in the first year after introduction of immunosuppressive therapy
Rate of CD45RC on circulating T lymphocytes the day of acute rejection
day of acute rejection
Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection
day of acute rejection
anti-HLA antibodies' dosage at the time of acute rejection
cytokines' dosage
describe cytokine profile

Full Information

First Posted
June 11, 2019
Last Updated
February 9, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03994497
Brief Title
Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
Acronym
ECLAT
Official Title
Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
February 2, 2026 (Anticipated)
Study Completion Date
February 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival. Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies. Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation. The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell. Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh. The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient in need of a kidney transplant
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
Blood samples the day of the surgery and 4 times during the next year. Blood samples and histological slides taken at each biopsy and if there is suspicion of rejection of the graft
Primary Outcome Measure Information:
Title
Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of CD45RC for patient with acute rejection suspicion
Description
acute rejection confirmed or not
Time Frame
12 months
Title
Rate of CD45RC on circulating T lymphocytes
Description
Evolution of the expression of CD45RC in the first year after introduction of immunosuppressive therapy
Time Frame
from date of randomization until the date of acute rejection, up to 12 months
Title
Rate of CD45RC on circulating T lymphocytes the day of acute rejection
Description
day of acute rejection
Time Frame
12 months
Title
Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection
Description
day of acute rejection
Time Frame
12 months
Title
anti-HLA antibodies' dosage at the time of acute rejection
Time Frame
12 months
Title
cytokines' dosage
Description
describe cytokine profile
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 and under 70 years old Patients in care for a first priority renal transplant. Patients with low immunological risk Patients with prior written informed consent Exclusion Criteria: Poor understanding of the French language Pregnant, breastfeeding or partying women Persons deprived of liberty by an administrative or judicial decision Persons undergoing psychiatric care under duress Adults who are subject to a legal or non-state protection measure to express their consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie GARNIER, MD
Phone
0241356075
Ext
+33
Email
AnneSophie.Garnier@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Béatrice GABLE
Email
begable@chu-angers.fr
Facility Information:
Facility Name
Dr Anne-Sophie GARNIER
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie GARNIER, Dr
Phone
2 41 35 44 76
Ext
+33
Email
annesophie.garnier@chu-angers.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation

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