Use of Predigraft in Kidney Transplant Patients

NCT ID: NCT04969757

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2025-05-25

Brief Summary

Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Hence the importance of regular monitoring to check that the graft is functioning properly, to adapt immunosuppressive treatments and to check for side effects related to the immunosuppressed state.

In conventional management, the patient is seen at regular intervals (ranging from 2 weeks to 3 months) in the referral transplant centre with recourse to hospitalisation if necessary. In the context of the COVID-19 pandemic, in order to reduce the risks of contamination, teleconsultations have been proposed to replace face-to-face consultations. Predigraft software facilitates remote patient assessment. This software provides an estimate of the probability of renal graft survival at 3, 5 and 7 years of the assessment based on an algorithm developed and validated by the U970 unit (Loupy A et al, BMJ 2019). The software also provides an application for patients allowing secure data transfer (biological analyses, blood pressure, weight). This allows the assessment of the need for additional patient evaluation based on usual monitoring parameters (creatinine, proteinuria) that can be done in the analysis laboratory near the patient's home.

A first evaluation of the use and acceptability among care professionals has been conducted between April and June 2020 and showed excellent results. It is now necessary to obtain real-life data to evaluate the use of the tool among patients and healthcare professionals and its impact on the organisation of care.

This is a prospective interventional study with minimal risks and constraints on the active file of transplant patients followed in ambulatory care for a period of 12 months.

The objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients.

Conditions

Kidney Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Predigraft

Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.

Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.

Group Type: EXPERIMENTAL

Predigraft group

Intervention Type: DEVICE

Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.

Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.

Interventions

Predigraft group

Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.

Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
• Patient over 18 years of age at the time of inclusion
• Stable renal function (glomerular filtration rate>60 mL/min or decision at physician's discretion) at the time of inclusion
• Informed patient with signed consent
• Patient with access to an internet connection with a valid email
• Enrolled in a social security scheme or beneficiary of such a scheme

Exclusion Criteria

• Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)
• Kidney transplant less than 1 month old
• Lack of recovery of kidney function following renal transplantation
• Patient unable to use the telemedicine tool
• Vulnerable participants (minors, protected adults, prisoners)
• Patient under State Medical Assistance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Necker - APHP

Paris, , France

Hopital Saint Louis - APHP

Paris, , France

Countries

France

Other Identifiers

APHP210379

Identifier Type: -

Identifier Source: org_study_id