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Clinical Impact of the iBox as an Early Intervention tooL

Primary Purpose

Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Predigraft
Sponsored by
Predict4Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Chronic Kidney Disease, Kidney Transplant, IBox, Predigraft, Kidney allograft, Prediction, Rejection, Allograft survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medizinische Universität Innsbruck
  • Hôpital Saint-Louis
  • Hôpital Necker
  • Hôpital Tenon
  • CHU Rangueil
  • Universitätsklinikum Düsseldorf AÖR
  • Universitätsklinikum Hamburg-Eppendorf
  • Sourasky Medical Center - Ichilov Hospital
  • Hospital Del Mar - Parc de Salut Mar
  • Fundació Puigvert
  • Hospital Universitari i Politècnic La Fe
  • Queen Elizabeth Hospital
  • Leeds Teaching Hospital NHS Trust
  • Guy's & Saint Thomas' NHS Foundation Trust
  • King's College Hospital
  • Oxford Transplant Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Predigraft

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

number of biopsies leading to therapeutic change
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
Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy.
Renal function
Renal function estimated by eGFR
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.
iBox predicted allograft survival
iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.
Number of therapeutic changes
Number of therapeutic changes by the end of the follow-up.
Number of unnecessary biopsies
Number of unnecessary biopsies by the end of the follow-up.

Full Information

First Posted
October 19, 2021
Last Updated
August 21, 2023
Sponsor
Predict4Health
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1. Study Identification

Unique Protocol Identification Number
NCT05112315
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Predict4Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized 1:1 , controlled, open label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Predigraft
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will have a clinical follow-up based on site standard of care.
Intervention Type
Device
Intervention Name(s)
Predigraft
Other Intervention Name(s)
Remote monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of biopsies leading to therapeutic change
Description
number of biopsies leading to therapeutic change by the end of the follow-up (18 months).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Lapse of time between the detection of kidney allograft instability and the biospy
Description
Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy.
Time Frame
18 months
Title
Renal function
Description
Renal function estimated by eGFR
Time Frame
18 months
Title
Patient outcome
Description
Patient outcome evaluated by a composite endpoint: graft loss + patient death + eGFR < 30 mL/min/1.73m2 by the end of the follow-up.
Time Frame
18 months
Title
iBox predicted allograft survival
Description
iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.
Time Frame
18 months
Title
Number of therapeutic changes
Description
Number of therapeutic changes by the end of the follow-up.
Time Frame
18 months
Title
Number of unnecessary biopsies
Description
Number of unnecessary biopsies by the end of the follow-up.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Patient related outcome measures
Description
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.
Time Frame
18 months
Title
Medico-economic evaluation
Description
Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre LOUPY, Pr
Organizational Affiliation
Necker Hospital, Paris, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmen LEFAUCHEUR, Pr
Organizational Affiliation
St Louis Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Universitätsklinikum Düsseldorf AÖR
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Sourasky Medical Center - Ichilov Hospital
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hospital Del Mar - Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Leeds Teaching Hospital NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's & Saint Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Oxford Transplant Centre
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be communicated to other researchers in an aggregated manner

Learn more about this trial

Clinical Impact of the iBox as an Early Intervention tooL

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