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Recruiting Phase 3

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

NCT06235892 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2024-12-10
Last updated
2026-06-03

Condition(s) studied

Organ Grafts

Investigational drug(s) / intervention(s)

TACROLIMUS →

TACROLIMUS: TACROLIMUS 2-3.5 ng/ml

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus — Month 18
    Improvement will be assessed by measured glomerular filtration rate (mGFR) iohexol clearance.

Trial sites (3)

FacilityCityRegionStatus
CHU de NANTES Nantes France Recruiting
Oslo University Hospital Oslo Norway Not Yet Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06235892 on ClinicalTrials.gov ↗ ← All trials in Spain