RecruitingPhase 3NCT06235892

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

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


Sponsor

Nantes University Hospital

Enrollment

300 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called TACROLIMUS for people with organ grafts. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTACROLIMUS

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

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NCT06235892