Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT04969757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-17
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Predigraft in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who have logged on to the Predigraft application at least 3 times', 'timeFrame': 'at 12 months from study inclusion'}], 'secondaryOutcomes': [{'measure': 'French version of Functional, Communicative and Critical Health Literacy (FCCHL) scale', 'timeFrame': 'at inclusion', 'description': '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.'}, {'measure': 'French version of Functional, Communicative and Critical Health Literacy (FCCHL)', 'timeFrame': 'at 12 months after inclusion', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Quality of life evaluating using SF36', 'timeFrame': 'at 6 weeks', 'description': '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.'}, {'measure': 'Quality of life evaluated using SF36', 'timeFrame': 'at 12 months', 'description': '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.'}, {'measure': 'Medication adherence', 'timeFrame': 'at inclusion', 'description': '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.'}, {'measure': 'Medication adherence', 'timeFrame': 'at 6 weeks', 'description': '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.'}, {'measure': 'Medication adherence', 'timeFrame': 'at 12 months', 'description': '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.'}, {'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', 'description': '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.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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.\n\nA 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.\n\nThis 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.\n\nThe objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago\n* Patient over 18 years of age at the time of inclusion\n* Stable renal function (glomerular filtration rate\\>60 mL/min or decision at physician's discretion) at the time of inclusion\n* Informed patient with signed consent\n* Patient with access to an internet connection with a valid email\n* Enrolled in a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)\n* Kidney transplant less than 1 month old\n* Lack of recovery of kidney function following renal transplantation\n* Patient unable to use the telemedicine tool\n* Vulnerable participants (minors, protected adults, prisoners)\n* Patient under State Medical Assistance"}, 'identificationModule': {'nctId': 'NCT04969757', 'acronym': 'PREDIGRAFT2', 'briefTitle': 'Use of Predigraft in Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Use of the Predigraft Platform (a Remote Monitoring Solution for Predicting Kidney Graft Survival) in Kidney Transplant Patients', 'orgStudyIdInfo': {'id': 'APHP210379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Predigraft', 'description': "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.\n\nPhysicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.", 'interventionNames': ['Device: Predigraft group']}], 'interventions': [{'name': 'Predigraft group', 'type': 'DEVICE', 'description': "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.\n\nPhysicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years.", 'armGroupLabels': ['Predigraft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}