Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT03994497

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

Led by University Hospital, Angers · Updated on 2024-06-11

150

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 and under 70 years old
  • Patients receiving their first priority kidney transplant
  • Patients with low immunological risk
  • Patients who have provided written informed consent
Not Eligible

You will not qualify if you...

  • Poor understanding of the French language
  • Women who are pregnant, breastfeeding, or planning pregnancy
  • Individuals deprived of liberty by administrative or judicial decision
  • Persons undergoing psychiatric care under duress
  • Adults under legal or non-state protection measures for consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dr Anne-Sophie GARNIER

Angers, France

Actively Recruiting

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Research Team

A

Anne-Sophie GARNIER, MD

CONTACT

B

Béatrice GABLE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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