Clinical Impact of the IBox As an Early Intervention TooL

NCT05112315 | Active Not Recruiting

• 1 other identifier: TF-Form-124
• Study Type: interventional
• Target: 507
• Locations: 6 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Lapse of time between the detection of kidney allograft instability and the biospy

  18 months

• Renal function

  18 months

• Patient outcome

  18 months

• iBox predicted allograft survival

  18 months

• Number of therapeutic changes

  18 months

Other Outcomes (2)

• Patient related outcome measures

  18 months

• Medico-economic evaluation

  18 months

Study Arms (2)

Predigraft

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

Predigraft DEVICE

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.

Also known as: Remote monitoring

Predigraft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age ≥ 18 years old at the time of consent.
• Patients receiving a living or deceased donor kidney allograft.
• Patients who signed the informed consent form and are willing to comply with study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Predict4Health: lead

Study Sites (16)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Hôpital Saint-Louis

Paris, France, 75010, France

Location

Hôpital Tenon

Paris, France, 75020, France

Location

CHU Rangueil

Toulouse, France, 31400, France

Location

Hôpital Necker

Paris, 75015, France

Location

Universitätsklinikum Düsseldorf AÖR

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Sourasky Medical Center - Ichilov Hospital

Tel Aviv, 6423906, Israel

Location

Hospital Del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

Fundació Puigvert

Barcelona, 08025, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Guy's & Saint Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Oxford Transplant Centre

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Rejection, Psychology

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Alexandre LOUPY, Pr

  Necker Hospital, Paris, France

  STUDY CHAIR

• Carmen LEFAUCHEUR, Pr

  St Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized 1:1 , controlled, open label study

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 8, 2021
• Study Start: February 18, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); ES (3); FR (4); IL (1); GB (5); DE (2)