Trials / Active Not Recruiting
Active Not RecruitingNCT05112315
Clinical Impact of the IBox As an Early Intervention TooL
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.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 507 (actual)
- Sponsor
- Predict4Health · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Kidney Diseases
- Kidney Disease, Chronic
- Kidney Transplant Rejection
- Kidney Transplant; Complications
- Kidney Failure
- Kidney Failure, Chronic
- Kidney Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-02-18
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2021-11-08
- Last updated
- 2024-10-04
Locations
16 sites across 6 countries: Austria, France, Germany, Israel, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05112315. Inclusion in this directory is not an endorsement.