Use of Predigraft in Kidney Transplant Patients

Kidney Transplant Clinical Trial

— PREDIGRAFT2  

Official title:

Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04969757
• Other study ID #: APHP210379
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Carmen Lefaucheur, Pr
• Phone: 01 42 49 96 05
• Email: carmen.lefaucheur[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who have logged on to the Predigraft application at least 3 times		at 12 months from study inclusion
Secondary	French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale	For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score = 4 corresponds to a low level of literacy.	at inclusion
Secondary	French version of Functional, Communicative and Critical Health Literacy (FCCHL)	For each subscale of the FCCHL, the literacy score can range from 1 (low) to 5 (high). An overall score is calculated from the scores of the three subscales. A score = 4 corresponds to a low level of literacy.	at 12 months after inclusion
Secondary	Connection time		at 12 months after inclusion
Secondary	Connection frequency		at 12 months after inclusion
Secondary	Time between two connections		at 12 months after inclusion
Secondary	Proportion of fonction used		at 12 months after inclusion
Secondary	Quality of life evaluating using SF36	Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.	at inclusion
Secondary	Quality of life evaluating using SF36	Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.	at 6 weeks
Secondary	Quality of life evaluated using SF36	Quality of life evaluated using MOS SF36 questionnaire (Medical Outcomes Study - 36-Item Short Form Health Survey). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 assesses different dimensions of feeling healthy and well being using 11 questions.These measures rely upon patient self-reporting.. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). A high score means a better quality of life.	at 12 months
Secondary	Medication adherence	Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.	at inclusion
Secondary	Medication adherence	Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.	at 6 weeks
Secondary	Medication adherence	Medication adherence will be evaluation using the Basel Assessment of Adherence Scale Immunosuppression Scale (BAASIS scale). This is a self-assessment scale to evaluate medication adherence.	at 12 months
Secondary	Proportion of hospitalisations		at 12 months after inclusion
Secondary	Proportion of consultations		at 12 months after inclusion
Secondary	Proportion of emergency consultations or hospitalisations		at 12 months after inclusion
Secondary	Overall survival		at 12 months after inclusion
Secondary	Rejection and dialysis free survival		at 12 months after inclusion
Secondary	Cumulative incidence of graft rejection		at 12 months after inclusion
Secondary	Proportion of patients with deteriorated renal function	Renal function deterioration will be defined as an estimated glomerular filtration rate < 30 ml/min/1.73m2 according to the MDRD equation and/or, a 10% decrease between inclusion and 12 months after inclusion.	at 12 months after inclusion
Secondary	Probability of graft survival		at inclusion
Secondary	Probability of graft survival		up to 12 months
Secondary	Probability of graft survival		at 12 months
Secondary	Time from date of graft to date of non-protocol DSA		up to 12 months post-inclusion
Secondary	Time from date of graft to date of non-protocol biopsy		up to 12 months post-inclusion