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Recruiting NCT06235892

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

Phase III Interventional Organ Grafts

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TACROLIMUS.
Who it may be relevant to
Registry conditions: Organ Grafts. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Norway, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug TACROLIMUS
    TACROLIMUS 2-3.5 ng/ml

Primary outcome measures

  • Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus [Time frame: Month 18]
Secondary outcome measures (8)
  • Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions) [Time frame: Month 18]
  • Type, severity and treatment of biopsy-proven acute rejection ( BPAR) [Time frame: Month 18]
  • Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500) [Time frame: Month 18]
  • Appearance or worsening of histological lesions of interstitial fibrosis and inflammatory tubular atrophy (IFTA) of study biopsy by considering that only patients with normal histology or with an IFTA-1 or 2will be randomized [Time frame: Month 18]
  • Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study [Time frame: Month 18]
  • Prevalence of metabolic disorders: post-transplant diabetes mellitus (PTDM), dyslipidaemia and hypertension at end of study [Time frame: Month 18]
  • Treatment adherence consisting in monitoring immunosuppression adherence using Trackyourmed® to monitor individual variability tacrolimus intake [Time frame: Month 18]
  • Change in quality of life estimated using the EQ-5D ( EuroQol instrument - dimensions) questionnaire fulfilled by patients at baseline, Month 3, Month 6, Month 9, Month 12, Month15 and Month18 [Time frame: Month 3, Month 6, Month 9, Month 12, Month15 and Month18]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de NANTES — Nantes
Norway · 1 center
  • Oslo University Hospital — Oslo
Spain · 1 center
  • Hospital Universitari Vall d'Hebron — Barcelona

Identifiers

NCT: NCT06235892 · RC22_0525

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗