Clinical Impact of the IBox As an Early Intervention TooL

Clinical Impact of the IBox As an Early Intervention TooL: a Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.

International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

The study aims to demonstrate improvement of the prevalence of biopsies leading to therapeutic change in the Predigraft group compared to the Standard of care group in kidney transplanted patients.

It is hypothesized that using Predigraft as a monitoring tool will help the physician detect earlier and more often abnormalities with the patient allograft. This should lead to an increased number of biopsies leading to therapeutic change. These biopsies should be performed earlier than without the iBox monitoring tool. This would improve long-term allograft function, kidney allograft and patient survival.

Inclusion Criteria:

• Men and women, age ≥ 18 years old at the time of consent.
• Patients receiving a living or deceased donor kidney allograft.
• Patients transplanted at least 3 months before inclusion.
• Patients who signed the informed consent form and are willing to comply with study procedures.

Exclusion Criteria:

• Combined transplant (i.e. heart-kidney, liver-kidney).
• Patients who are unable or unwilling to comply with study procedures.
• Vulnerable patients (minors, protected adults, legally detained).
• Patients participating in other interventional studies.