Use of Predigraft in Kidney Transplant Patients

NCT04969757 | Completed

• 1 other identifier: APHP210379
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who have logged on to the Predigraft application at least 3 times

  at 12 months from study inclusion

Secondary Outcomes (24)

• French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale

  at inclusion

• French version of Functional, Communicative and Critical Health Literacy (FCCHL)

  at 12 months after inclusion

• Connection time

  at 12 months after inclusion

• Connection frequency

  at 12 months after inclusion

• Time between two connections

  at 12 months after inclusion

Study Arms (1)

Predigraft

EXPERIMENTAL

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.

Device: Predigraft group

Interventions

Predigraft group 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.

Predigraft

Eligibility Criteria

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

You may qualify if:

• Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hopital Necker - APHP

Paris, France

Location

Hopital Saint Louis - APHP

Paris, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 21, 2021
• Study Start: November 23, 2021
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (2)