Clinical Impact of the iBox as an Early Intervention tooL

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

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

Intervention / Treatment
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* Device: Predigraft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized 1:1 , controlled, open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Predigraft<br>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. | Device: Predigraft<br>* The Subject randomized to the Predigraft will benefit from Predigraft, a remote monitoring software that issues an alert to the investigator when the allograft survival prediction calculated by the iBox algorithm is decreasing. This follow-up is on top of the site's standard of care.<br>* Other names: Remote monitoring;|
| No Intervention: Standard of Care<br>Subjects will have a clinical follow-up based on site standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of biopsies leading to therapeutic change | number of biopsies leading to therapeutic change by the end of the follow-up (18 months). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lapse of time between the detection of kidney allograft instability and the biospy | Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy. | 18 months | 
| Renal function | Renal function estimated by eGFR | 18 months | 
| Patient outcome | Patient outcome evaluated by a composite endpoint: graft loss + patient death + eGFR < 30 mL/min/1.73m2 by the end of the follow-up. | 18 months | 
| iBox predicted allograft survival | iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up. | 18 months | 
| Number of therapeutic changes | Number of therapeutic changes by the end of the follow-up. | 18 months | 
| Number of unnecessary biopsies | Number of unnecessary biopsies by the end of the follow-up. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Kidney Transplant, IBox, Predigraft, Kidney allograft, Prediction, Rejection, Allograft survival