Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 7:58 PM
Study NCT ID:
NCT06728995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Function Prediction in Living Donor Transplant Using Baseline Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-02', 'size': 255533, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T04:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowest Serum Creatinine Level', 'timeFrame': 'Within one year post-transplant.', 'description': 'Measurement of the lowest serum creatinine level post-transplant to evaluate kidney function.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal transplantation', 'kidney volume', 'predictive model', 'machine learning'], 'conditions': ['Renal Transplanted Recipients', 'Kidney Function']}, 'descriptionModule': {'briefSummary': 'This study aims to predict early post-transplant kidney function in living donor kidney transplant recipients using baseline characteristics of donors and recipients. The study involves analyzing pre-transplant data to develop a machine learning model that predicts serum creatinine levels one year post-transplant. This research may improve decision-making and outcomes for transplant patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants were recruited from Seoul National University Hospital, Severance Hospital, and Bundang Seoul National University Hospital, encompassing recipients and donors involved in living-donor kidney transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Recipients and donors of living-donor kidney transplantation.\n\nExclusion Criteria:\n\n* Donors or recipients with follow-up durations of less than 1 year.\n* Recipients who received simultaneous organ transplantation in addition to kidney transplantation.'}, 'identificationModule': {'nctId': 'NCT06728995', 'briefTitle': 'Renal Function Prediction in Living Donor Transplant Using Baseline Data', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prediction of Recipient Renal Function in Living Donor Kidney Transplantation Using Baseline Characteristics and Donor Renal Volume', 'orgStudyIdInfo': {'id': 'SNUH-Volumetry_KT Recipient'}, 'secondaryIdInfos': [{'id': 'H-2205-051-1322', 'type': 'OTHER', 'domain': 'Seoul National University Hospital Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Population', 'description': 'All participants included in the retrospective study who underwent living-donor kidney transplantation. No interventions were applied as this is an observational study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified participant data will be made available to researchers upon reasonable request, subject to approval by the IRB'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang-Il Min, MD, PhD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}