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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
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
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