Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 1:24 PM
Study NCT ID:
NCT05238220
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-27', 'releaseDate': '2025-06-11'}, {'resetDate': '2025-09-23', 'releaseDate': '2025-09-04'}], 'estimatedResultsFirstSubmitDate': '2025-06-11'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077562', 'term': 'Valganciclovir'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of Viracor CMV immunity assay', 'timeFrame': '6 months post-transplant through 12 months prophylaxis', 'description': 'continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.', 'detailedDescription': 'Kidney transplant patients that are cytomegalovirus (CMV) seronegative (IgG negative) at time of transplant and receive a graft from a donor that is CMV seropositive (IgG positive) are at increased risk of developing post-transplant CMV viremia and disease. These patients receive standard CMV prophylaxis with valganciclovir for 6 months post-transplant. However, a considerable proportion of these patients (25 - 42% at our center over the last 5 years) will go on to develop CMV viremia and/or disease after this valganciclovir prophylaxis is discontinued. To date, there is no strong data regarding whether certain patients would benefit from extension of valganciclovir prophylaxis beyond the standard 6-month period.\n\nThe purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CMV High Risk Kidney Transplant Recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide consent\n* Kidney Transplant Recipients\n* Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05238220', 'briefTitle': 'Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Piedmont Healthcare'}, 'officialTitle': 'Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'Viracor'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'continue valganciclovir prophylaxis', 'description': 'continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent', 'interventionNames': ['Drug: Valganciclovir']}, {'label': 'discontinue valganciclovir prophylaxis', 'description': 'discontinue valganciclovir prophylaxis when anti-CMV immunity present after routine care prophylaxis'}], 'interventions': [{'name': 'Valganciclovir', 'type': 'DRUG', 'description': 'continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity', 'armGroupLabels': ['continue valganciclovir prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Atlanta Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Piedmont Healthcare', 'class': 'OTHER'}, 'collaborators': [{'name': 'ViraCor Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Transplant Nephrologist', 'investigatorFullName': 'Christina Klein', 'investigatorAffiliation': 'Piedmont Healthcare'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-11', 'type': 'RELEASE'}, {'date': '2025-06-27', 'type': 'RESET'}, {'date': '2025-09-04', 'type': 'RELEASE'}, {'date': '2025-09-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Christina Klein, Transplant Nephrologist, Piedmont Healthcare'}}}}