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ECLATCD45RC Expression on T Lymphocytes as Acute Rejection Predictor in Renal Transplantation

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Study Aim

This study aims to screen and determine if CD45RC expression on T Lymphocytes can predict acute rejection in individuals who have undergone a kidney transplant, confirmed through an analysis of a graft biopsy.

What is being tested

Blood samples

Other
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 70 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorUniversity Hospital, Angers
Study ContactAnne-Sophie GARNIER, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 3, 2021

Actual date on which the first participant was enrolled.

Chronic renal failure is a significant health issue, affecting millions of people worldwide. Renal transplantation is the best treatment option for end-stage renal failure, offering improved patient survival compared to other treatments. However, a common challenge is allograft rejection, which occurs in 15% to 25% of cases within the first year and can lower the survival rate of the transplanted kidney. While certain risk factors like the recipient's young age or a high number of human leukocyte antigen (HLA) incompatibilities have been identified, they do not accurately predict the risk of acute rejection. This study aims to find reliable biomarkers that can predict allograft tolerance before transplantation, a major goal in renal transplantation. Researchers have found that the level of expression of a molecule called CD45RC on T lymphocytes (a type of white blood cell) is associated with an increased risk of acute rejection. This study seeks to confirm these initial findings in a larger, more contemporary regional group of patients. In this study, participants will undergo regular check-ups and monitoring. The primary focus is to measure the number of patients who develop acute rejection, which will be confirmed through an anatomopathological analysis of a graft biopsy. This involves examining a small sample of tissue from the transplanted kidney under a microscope. The study aims to understand the role of CD45RC expression in predicting acute rejection, which could potentially lead to improved and more personalized immunosuppressive strategies for renal transplant patients.

Official TitleEvaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
NCT03994497
Principal SponsorUniversity Hospital, Angers
Study ContactAnne-Sophie GARNIER, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Participants in this group are patients who need a kidney transplant. They will provide blood samples on the day of surgery and four times during the following year. Additional samples may be taken if there's a suspicion of graft rejection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dr Anne-Sophie GARNIER

Angers, FranceOpen Dr Anne-Sophie GARNIER in Google Maps
Recruiting
One Study Center