Clinical trial NCT04969757: Use of Predigraft in Kidney Transplant Patients
Official title: Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Transplant
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of patients who have logged on to the Predigraft application at least 3 times
timeFrame: at 12 months from study inclusion
Secondary outcomes:
measure: French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale
timeFrame: at inclusion
measure: French version of Functional, Communicative and Critical Health Literacy (FCCHL)
timeFrame: at 12 months after inclusion
measure: Connection time
timeFrame: at 12 months after inclusion
measure: Connection frequency
timeFrame: at 12 months after inclusion
measure: Time between two connections
timeFrame: at 12 months after inclusion
measure: Proportion of fonction used
timeFrame: at 12 months after inclusion
measure: Quality of life evaluating using SF36
timeFrame: at inclusion
measure: Quality of life evaluating using SF36
timeFrame: at 6 weeks
measure: Quality of life evaluated using SF36
timeFrame: at 12 months
measure: Medication adherence
timeFrame: at inclusion
measure: Medication adherence
timeFrame: at 6 weeks
measure: Medication adherence
timeFrame: at 12 months
measure: Proportion of hospitalisations
timeFrame: at 12 months after inclusion
measure: Proportion of consultations
timeFrame: at 12 months after inclusion
measure: Proportion of emergency consultations or hospitalisations
timeFrame: at 12 months after inclusion
measure: Overall survival
timeFrame: at 12 months after inclusion
measure: Rejection and dialysis free survival
timeFrame: at 12 months after inclusion
measure: Cumulative incidence of graft rejection
timeFrame: at 12 months after inclusion
measure: Proportion of patients with deteriorated renal function
timeFrame: at 12 months after inclusion
measure: Probability of graft survival
timeFrame: at inclusion
measure: Probability of graft survival
timeFrame: up to 12 months
measure: Probability of graft survival
timeFrame: at 12 months
measure: Time from date of graft to date of non-protocol DSA
timeFrame: up to 12 months post-inclusion
measure: Time from date of graft to date of non-protocol biopsy
timeFrame: up to 12 months post-inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker - APHP
city: Paris
country: France
facility: Hopital Saint Louis - APHP
Study officials:
References: