Clinical Impact of the IBox As an Early Intervention TooL

Predict4Health

Status: Active, not recruiting

Conditions: Kidney Failure; Kidney Diseases; Kidney Transplant; Complications; Kidney Disease, Chronic; Kidney Dysfunction; Kidney Failure, Chronic; Kidney Transplant Rejection

Treatments: Device: Predigraft

Study type: Interventional

Funder types: Industry

Identifiers

NCT05112315

TF-Form-124

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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507 participants in 2 patient groups

Predigraft

Experimental group

Description:

Subjects will have a clinical follow-up based on site standard of care and benefit from follow-up using Predigraft in addition of the standard of care: the investigator will receive an alert every time there is a subject's instability, instability based on the following criteria: allograft survival assessed by iBox decreased by at least 5% in the last 12 months.

Treatment:

Device: Predigraft

Standard of Care

No Intervention group

Description:

Subjects will have a clinical follow-up based on site standard of care.