Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure (AGORAC)

Nantes University Hospital (NUH)

Status and phase: Enrolling; Phase 3

Conditions: Organ Grafts

Treatments: Drug: TACROLIMUS

Study type: Interventional

Funder types: Other

Identifiers

NCT06235892

RC22_0525

Details and patient eligibility

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.

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Ultra-low TACROLIMUS arm

Experimental group

Description:

Ultra-low TACROLIMUS (TAC) arm based on MMF/MPA (Mycophenolate Mofetil/ Mycophénolic Acid) with or without CS (Cortico Steroid ) and TACROLIMUS to achieve 2-3.5 ng/ml trough levels during all the duration of the study.

Treatment:

Drug: TACROLIMUS

SOC ( Standard of care)-TACROLIMUS arm

No Intervention group

Description:

SOC-TAC arm based on MMF/MPA with or without CS and TACROLIMUS to achieve 4 and 7 ng/ml trough levels during all the duration of the study