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Clinical Impact of the IBox As an Early Intervention TooL

NCT05112315 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Predict4Health

    lead INDUSTRY

Principal Investigators

  • Alexandre LOUPY, Pr · Necker Hospital, Paris, France

  • Carmen LEFAUCHEUR, Pr · St Louis Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Austria
  • France
  • Germany
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112315 on ClinicalTrials.gov