Clinical Impact of the iBox as an Early Intervention tooL (CIBIL)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Diseases; Kidney Failure, Chronic; Kidney Transplant Rejection; Kidney Disease, Chronic; Kidney Failure; Kidney Transplant; Complications; Kidney Dysfunction
• Intervention / Treatment: Device: Predigraft

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 Type: Interventional
• Enrollment (Actual): 507
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitat Innsbruck
• France
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Paris, France, 75015
    • Hopital Necker
  • Toulouse, France, 31400
    • CHU Rangueil
• Germany
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf AÖR
  • Hamburg, Germany, 20251
    • Universitätsklinikum Hamburg-Eppendorf
• Israel
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center - Ichilov Hospital
• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert
  • Barcelona, Spain, 08003
    • Hospital del Mar - Parc de Salut Mar
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospital NHS Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's & Saint Thomas' NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LE
    • Oxford Transplant Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Renal function	Renal function estimated by eGFR	18 months
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
iBox predicted allograft survival	iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.	18 months
Number of therapeutic changes	Number of therapeutic changes by the end of the follow-up.	18 months
Number of unnecessary biopsies	Number of unnecessary biopsies by the end of the follow-up.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Medico-economic evaluation	Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months	18 months

Collaborators and Investigators

• Sponsor: Predict4Health
• Investigators: Study Chair: Alexandre LOUPY, Pr, Necker Hospital, Paris, France; Principal Investigator: Carmen LEFAUCHEUR, Pr, St Louis Hospital, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rejection; Chronic Kidney Disease; Prediction; Kidney Transplant; Kidney allograft; IBox; Predigraft; Allograft survival
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: TF-Form-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be communicated to other researchers in an aggregated manner

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No