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Clinical Impact of the iBox as an Early Intervention tooL

Kidney Diseases Clinical Trial

Official title:
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.

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05112315
Study type Interventional
Source Predict4Health
Contact
Status Active, not recruiting
Phase N/A
Start date February 18, 2022
Completion date November 2024
View Details
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