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

NCT06235892 | Recruiting Phase 3 DMC

• 1 other identifier: RC22_0525
• Study Type: interventional
• Target: 332
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Organ Grafts

Keywords

Tacrolimus minimization; kidney transplant; AGORA Algorithm

Outcome Measures

Primary Outcomes (1)

• Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus

  Improvement will be assessed by measured glomerular filtration rate (mGFR) iohexol clearance.

  Month 18

Secondary Outcomes (8)

• Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions)

  Month 18

• Type, severity and treatment of biopsy-proven acute rejection ( BPAR)

  Month 18

• Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500)

  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

  Month 18

• Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study

  Month 18

Study Arms (2)

Ultra-low TACROLIMUS arm

EXPERIMENTAL

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.

Drug: TACROLIMUS

SOC ( Standard of care)-TACROLIMUS arm

NO INTERVENTION

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

Interventions

TACROLIMUS DRUG

TACROLIMUS 2-3.5 ng/ml

Ultra-low TACROLIMUS arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First kidney transplantation
• Living or brain death or
• Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor,
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHU de NANTES

Nantes, 44000, France

RECRUITING

Oslo University Hospital

Oslo, Norway

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Magali GIRAL

CONTACT

+33240087443; magali.giral@chu-nantes.fr

Sonia Brinet

CONTACT

+33253526126

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); FR (1); ES (1)