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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-10-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Organ Grafts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultra-low TACROLIMUS arm

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.

Group Type EXPERIMENTAL

TACROLIMUS

Intervention Type DRUG

TACROLIMUS 2-3.5 ng/ml

SOC ( Standard of care)-TACROLIMUS arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TACROLIMUS

TACROLIMUS 2-3.5 ng/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No