Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic renal failure is a widespread health issue, affecting about 3 million people in France, with significant social and economic impacts. At the final stage of this condition, kidney transplantation is considered the best treatment option, improving patient survival compared to other methods like dialysis. Despite advances in immunosuppressive treatments, acute rejection of the transplanted kidney remains common, occurring in 15% to 25% of cases within the first year. This rejection is linked to lower survival of the kidney graft. Researchers aim to find biomarkers that predict the risk of acute rejection before transplantation to better personalize immunosuppressive therapies. One such potential biomarker is the level of CD45RC expression on T lymphocytes, which has been associated with increased rejection risk in earlier studies. This study will measure the expression levels of CD45RC on T lymphocytes in patients undergoing their first kidney transplant with low immunological risk. Blood samples will be collected on the day of the transplant surgery and four additional times over the following year. Additional samples and tissue slides will be taken during biopsies or if rejection is suspected. The study seeks to confirm previous findings that a higher percentage of CD8+ T cells expressing high CD45RC levels before transplant is linked to greater risk of acute rejection. Participants will be monitored for up to 12 months after their transplant. Researchers will assess acute rejection by analyzing kidney biopsy tissue and measuring various immune markers and antibodies in the blood. They will also track cytokine levels on the day of transplantation. The primary outcome is the number of patients diagnosed with acute rejection confirmed by biopsy. Secondary outcomes include changes in CD45RC and other immune cell markers during rejection episodes. Safety and graft status will be closely observed throughout the study period.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Patients over 18 and under 70 years old
- Patients receiving a first priority kidney transplant
- Patients with low immunological risk
- Patients who have given prior written informed consent
You will not qualify if you...
- Poor understanding of the French language
- Pregnant, breastfeeding, or menstruating women
- Persons deprived of liberty by administrative or judicial decision
- Persons under compulsory psychiatric care
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 months
Participants who undergo routine kidney transplant care are observed with blood samples taken to monitor biomarkers related to acute rejection.
5 blood sample visits: the day of surgery and 4 times during the following year, plus additional samples at each biopsy or if graft rejection is suspected
Trial Site Locations
Total: 1 location
1
Dr Anne-Sophie GARNIER
Angers, France
Actively Recruiting
Research Team
A
Anne-Sophie GARNIER, MD
B
Béatrice GABLE
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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