Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
Prospective, Multicenter, Randomized, Open-label, Parallel-group Controlled Phase 3 Study of Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
Nantes University Hospital
332 participants
Dec 10, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- First kidney transplantation
- Living or brain death or
- Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor,
- cPRA (Panel Reactive Antibody Calculated ) (or TGI: Incompatible Graft Rate )<20% on the day of the transplantation and no DSA (MFI <500) at pre transplant and at the time of the inclusion at one-year post transplantation (between 350 and 515 days after the transplantation.
- Eplet Mismatchs <= 14
- Normal or IFTA 1-2 histology on one-year surveillance biopsy.
- Patient insured under a health insurance scheme, according to national regulation.
- Patient (of childbearing age) with effective contraception.
- Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS (Mycophenolate Sodium) +/- Corticosteroid (CS)
Exclusion Criteria8
- Donation after circulatory death maastricht 2 (uncontrolled) and maastricht 1
- Pregnant women (serum or urine test), breastfeeding women
- Patient under legal protection (incl. under guardianship or trusteeship)
- Participation to a drug interventional study within 1 month prior to the inclusion
- Any retransplantation and combined transplantations and also other organ previous transplantations
- History of lymphoproliferative disorders
- Diagnosis of a malignant disease (according to the type of malignancy)
- Hepatitis C antibody or hepatitis B surface antigen (HbsAg) positive patient or HIV infection
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Interventions
TACROLIMUS 2-3.5 ng/ml
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06235892