Actively Recruiting
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
Led by Nantes University Hospital · Updated on 2025-06-13
332
Participants Needed
3
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is that validation of the non-invasive biomarkers of the AGORA algorithm should make it possible to select patients with a very low immunological risk of graft failure to authorize safe minimization of their immunosuppression for adult patients at one-year post kidney transplantation. The main question of the AGORAC trial is to demonstrate the impact of TACROLIMUS minimization using AGORA algorithm compared to standard of care on the kidney function 18 months after the minimization period.
CONDITIONS
Official Title
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First kidney transplantation
- Donor is living, brain death, or donation after circulatory death (Maastricht 3)
- Compatible ABO blood group with donor
- cPRA (Panel Reactive Antibody) below 20% on transplantation day and no donor-specific antibodies (MFI <500) before transplant and at inclusion (between 350 and 515 days post-transplant)
- Eplet mismatches less than or equal to 14
- Normal or IFTA 1-2 histology on one-year surveillance biopsy
- Patient insured under a health insurance scheme
- Effective contraception for patients of childbearing age
- Patients treated with Tacrolimus and MMF/MPS, with or without corticosteroids
You will not qualify if you...
- Donation after circulatory death Maastricht 1 or Maastricht 2 (uncontrolled)
- Pregnant or breastfeeding women
- Patients under legal protection such as guardianship or trusteeship
- Participation in a drug interventional study within 1 month prior to inclusion
- Any retransplantation, combined transplantations, or prior other organ transplants
- History of lymphoproliferative disorders
- Diagnosis of malignant disease (depending on type)
- Positive for hepatitis C antibody, hepatitis B surface antigen, or HIV infection
AI-Screening
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Trial Site Locations
Total: 3 locations
1
CHU de NANTES
Nantes, France, 44000
Actively Recruiting
2
Oslo University Hospital
Oslo, Norway
Not Yet Recruiting
3
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Not Yet Recruiting
Research Team
M
Magali GIRAL
CONTACT
S
Sonia Brinet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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