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RECRUITING
NCT06235892
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2024-12-10

Completion Date

2026-10-10

Last Updated

2025-06-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

TACROLIMUS

TACROLIMUS 2-3.5 ng/ml

Locations (3)

CHU de NANTES

Nantes, France

Oslo University Hospital

Oslo, Norway

Hospital Universitari Vall d'Hebron

Barcelona, Spain