Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT00610961
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2008-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction Related BK Viremia in Renal Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-26', 'studyFirstSubmitDate': '2008-01-24', 'studyFirstSubmitQcDate': '2008-02-07', 'lastUpdatePostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)', 'timeFrame': 'One year', 'description': 'BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Acute Rejection of Transplanted Kidney', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BK Polyomavirus', 'Transplantation, Kidney', 'Transplantation, Pancreas'], 'conditions': ['Disease Due to BK Polyomavirus', 'Transplantation Infection', 'Disorder Related to Transplantation']}, 'descriptionModule': {'briefSummary': 'The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.', 'detailedDescription': 'Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.\n\nRetrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.\n\nProspective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).\n\nInductions in both groups was/is Standard of Care at a time of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'de novo renal or renal/pancrease transplant patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* De novo transplant\n* Aged 18-75\n\nExclusion Criteria:\n\n* Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.\n* Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol"}, 'identificationModule': {'nctId': 'NCT00610961', 'acronym': 'BK', 'briefTitle': 'Induction Related BK Viremia in Renal Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients', 'orgStudyIdInfo': {'id': '20071016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basiliximab (Simulect) Induction', 'description': 'Prospective group: patients are scheduled to receive a kidney transplant; and will receive Simulect®, Myfortic® and Prograf® with or without steroids according to routine care (Standard of Care).'}, {'label': 'Thymoglobulin Induction', 'description': 'Retrospective (historical or control) group: patients have already received a kidney transplant and were treated with Thymoglobulin®, Myfortic®, and Prograf® with or without steroids. This treatment was Standard of Care at a time of transplant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Herwig-Ulf Meier-Kriesche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}