Clinical trial NCT05112315: Clinical Impact of the IBox As an Early Intervention TooL
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Kidney Disease, Chronic
Kidney Transplant Rejection
Kidney Transplant; Complications
Kidney Failure
Kidney Failure, Chronic
Kidney Dysfunction
Keywords: Chronic Kidney Disease
Kidney Transplant
IBox
Predigraft
Kidney allograft
Prediction
Rejection
Allograft survival
Lead sponsor: Predict4Health
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized 1:1 , controlled, open label study
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of biopsies leading to therapeutic change
timeFrame: 18 months
Secondary outcomes:
measure: Lapse of time between the detection of kidney allograft instability and the biospy
timeFrame: 18 months
measure: Renal function
timeFrame: 18 months
measure: Patient outcome
timeFrame: 18 months
measure: iBox predicted allograft survival
timeFrame: 18 months
measure: Number of therapeutic changes
timeFrame: 18 months
measure: Number of unnecessary biopsies
timeFrame: 18 months
Other outcomes:
measure: Patient related outcome measures
timeFrame: 18 months
measure: Medico-economic evaluation
timeFrame: 18 months
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Tenon
city: Toulouse
country: France
facility: CHU Rangueil
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf AÖR
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center - Ichilov Hospital
city: Barcelona
country: Spain
facility: Hospital Del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
city: London
country: United Kingdom
facility: Guy's & Saint Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: Oxford
country: United Kingdom
facility: Oxford Transplant Centre
Study officials:
affiliation: Necker Hospital, Paris, France
name: Alexandre LOUPY, Pr
role: STUDY_CHAIR
affiliation: St Louis Hospital, Paris, France
name: Carmen LEFAUCHEUR, Pr
role: PRINCIPAL_INVESTIGATOR
References: