CIBIL, Version 1.1
Research type
Research Study
Full title
Clinical Impact of the iBox as an early Intervention tooL: A prospective randomized controlled trial to assess the use of a software predicting allograft survival in the follow-up of kidney transplanted patients.
IRAS ID
304974
Contact name
Sunil Daga
Contact email
Sponsor organisation
Predict4Health
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
CIBIL Study, sponsored by Cibiltech, is a prospective randomized controlled trial which aim to assess the use of Predigraft, a software predicting allograft survival in the follow-up of kidney transplanted patients.
It is an international, multicentre, randomized 1:1 study conducted in 17 centres in 7 countries. 450 patients with kidney transplants for at least 3 months will be included in 12 months and randomized to one of the two groups: standard follow-up or standard follow-up + Predigraft. Follow-up duration is 18 months.
Preliminary studies have shown that early detection of biopsy abnormalities in kidney transplant patients leads to early therapeutic adjustment, which results in a better probability of graft survival and thus delays graft rejection and patients’ return to dialysis. This constitutes a medico-economic benefit.
The CIBIL study primary objective is to improve the prevalence of biopsies leading to therapeutic change in the Predigraft group compared to the Standard of care group in kidney transplanted patients. We will therefore measure the number of biopsies leading to therapeutic change by the end of the follow-up.
REC name
HSC REC A
REC reference
22/NI/0036
Date of REC Opinion
23 Mar 2022
REC opinion
Further Information Favourable Opinion