CIBIL: Clinical Impact of the iBox as an Early Intervention tooL

Sponsor

Cibiltech (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05112315

Collaborator

(none)

450

Enrollment

Locations

Arms

29.4

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Kidney Disease, Chronic Kidney Transplant Rejection Kidney Transplant; Complications Kidney Failure Kidney Failure, Chronic Kidney Dysfunction	Device: Predigraft	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized 1:1 , controlled, open label studyrandomized 1:1 , controlled, open label study

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Feb 18, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Predigraft 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 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. Other Names: Remote monitoring
No Intervention: Standard of Care Subjects will have a clinical follow-up based on site standard of care.

Arm

Intervention/Treatment

Experimental: Predigraft

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

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.

Other Names:

Remote monitoring

No Intervention: Standard of Care

Subjects will have a clinical follow-up based on site standard of care.

Outcome Measures

Primary Outcome Measures

number of biopsies leading to therapeutic change [18 months]
number of biopsies leading to therapeutic change by the end of the follow-up (18 months).

Secondary Outcome Measures

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

Other Outcome Measures

Patient related outcome measures [18 months]
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.
Medico-economic evaluation [18 months]
Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Saint-Louis	Paris	France	75010
2	Hôpital Tenon	Paris	France	75020
3	CHU Rangueil	Toulouse	France	31400
4	Universitätsklinikum Düsseldorf AÖR	Düsseldorf	Germany	40225
5	Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany	20251
6	Fundació Puigvert	Barcelona	Spain	08025
7	Hospital Universitario 12 de Octubre	Madrid	Spain	28041
8	Hospital Universitari i Politècnic La Fe	Valencia	Spain	46026
9	Leeds Teaching Hospital NHS Trust	Leeds	United Kingdom	LS9 7TF
10	Guy's & Saint Thomas' NHS Foundation Trust	London	United Kingdom	SE1 9RT