Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06364618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Wearables to Detect Infections in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum at enrollment and then ad hoc at infection event'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of in-patient admissions', 'timeFrame': 'Periodically throughout the study, up to 24 months.', 'description': 'Any hospital admission for infection treatment is considered an event of this outcome'}, {'measure': 'Incidence of decrease/increase of Quality of Life', 'timeFrame': 'Periodically throughout the study, up to 24 months.', 'description': 'Score change of WHOQOL-BREF from baseline.'}], 'primaryOutcomes': [{'measure': 'Accuracy of the algorithm at detecting infections at presymptomatic stage', 'timeFrame': 'The primary endpoint will be assessed periodically throughout the study, up to 24 months.', 'description': 'Accuracy, sensitivity, specificity, negative and positive predictive value of the machine learning algorithm at detecting infections in presymptomatic stage in kidney transplant recipients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biometric data', 'continuous monitoring', 'machine learning', 'early alert system', 'infection', 'kidney transplantation'], 'conditions': ['Kidney Transplant Infection']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.\n\nThe main questions it aims to answer are:\n\n1. What are the biometric data pattern changes in impending infections?\n2. What accuracy the machine learning algorithm can achieve?\n\nParticipants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* kidney transplant recipient\n* age 18 years or more\n* kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)\n\nExclusion Criteria:\n\n* recipient of another transplanted organ\n* terminal failure of another organ (heart, liver, lung)\n* diabetes mellitus type 1\n* pregnant or breastfeeding woman\n* refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT06364618', 'acronym': 'RENALERT', 'briefTitle': 'Use of Wearables to Detect Infections in Kidney Transplant Recipients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'G-24-07'}}, 'contactsLocationsModule': {'locations': [{'zip': '14021', 'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Tereza Metelcova, PhD', 'role': 'CONTACT', 'email': 'tereza.metelcova@ikem.cz', 'phone': '+420261262125'}, {'name': 'Ivan Zahradka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vojtech Petr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katarina Jakubov, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute for Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Vojtech Petr, MD', 'role': 'CONTACT', 'email': 'petv@ikem.cz', 'phone': '720-639-0909'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Transplantation Center, Principal Investigator', 'investigatorFullName': 'Prof. Ondřej Viklický, M.D., Ph.D.', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}