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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05112315
• Other study ID #: TF-Form-124
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: Predict4Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 507
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Dysfunction
• Kidney Failure
• Kidney Failure, Chronic
• Kidney Transplant Rejection
• Kidney Transplant; Complications
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Predigraft
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.

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
France	Hôpital Necker	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris
France	CHU Rangueil	Toulouse
Germany	Universitätsklinikum Düsseldorf AÖR	Düsseldorf
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Israel	Sourasky Medical Center - Ichilov Hospital	Tel Aviv
Spain	Fundació Puigvert	Barcelona
Spain	Hospital Del Mar - Parc de Salut Mar	Barcelona
Spain	Hospital Universitari i Politècnic La Fe	Valencia
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds
United Kingdom	Guy's & Saint Thomas' NHS Foundation Trust	London
United Kingdom	King's College Hospital	London
United Kingdom	Oxford Transplant Centre	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Predict4Health

Countries where clinical trial is conducted

Austria,  France,  Germany,  Israel,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient related outcome measures	Patient related outcome measures: results of SF-36 (36-Item Short Form Health Survey) (quality of life: score 0 to 100 / 0 being the worst perception of health status) questionnaire at the end of the follow-up compared to baseline.	18 months
Other	Medico-economic evaluation	Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months	18 months
Primary	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	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
Secondary	Renal function	Renal function estimated by eGFR	18 months
Secondary	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
Secondary	iBox predicted allograft survival	iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.	18 months
Secondary	Number of therapeutic changes	Number of therapeutic changes by the end of the follow-up.	18 months
Secondary	Number of unnecessary biopsies	Number of unnecessary biopsies by the end of the follow-up.	18 months