Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT05072951
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Biomarker for Kidney Transplant Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biospecimen collection', 'timeFrame': '3 years after last enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Rejection']}, 'descriptionModule': {'briefSummary': 'An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and Female, at least 18 years of age with a kidney transplant prior to enrollment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide informed consent\n* Kidney Transplant\n\nExclusion Criteria:\n\n* Pediatric patients, under 18 years of age'}, 'identificationModule': {'nctId': 'NCT05072951', 'briefTitle': 'Urine Biomarker for Kidney Transplant Rejection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exosome Diagnostics, Inc.'}, 'officialTitle': 'An Adaptive Sample Collection to Evaluate a Biomarker for Kidney Transplant Rejection', 'orgStudyIdInfo': {'id': 'ECT2021-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Urine Biomarker for Kidney Transplant Rejection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biomarker for active kidney transplant rejection.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sonia Kumar, PhD', 'role': 'CONTACT', 'email': 'Sonia.Kumar@bio-techne.com', 'phone': '7816939600'}], 'overallOfficials': [{'name': 'Sonia Kumar', 'role': 'STUDY_CHAIR', 'affiliation': 'Exosome Diagnostics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exosome Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}