Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-01 @ 9:00 PM
Study NCT ID:
NCT01056835
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2010-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-24', 'studyFirstSubmitDate': '2010-01-24', 'studyFirstSubmitQcDate': '2010-01-24', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'graft pathology, serum creatinine, creatinine clearance, eGFR', 'timeFrame': '1 year after drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Allograft Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prevalent renal transplant recipients 2 years after transplantation\n* no history of acute rejection\n* stable renal function\n\nExclusion Criteria:\n\n* history of biopsy-proven chronic allograft nephropathy\n* history of biopsy-proven CNI nephrotoxicity\n* history of biopsy-proven or clinical acute rejection\n* unstable trough level of CNI or extremely low level of CNI\n* bleeding tendency(+)\n* pregnancy or pregnant-willing\n* anticoagulation(+)\n* antiplatelet agent (+)\n* significant comorbidity(+): Acute coronary syndrome, pneumonia'}, 'identificationModule': {'nctId': 'NCT01056835', 'briefTitle': 'Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy', 'orgStudyIdInfo': {'id': 'Beraprost-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'interventionNames': ['Drug: prostaglandin I2 analogue']}], 'interventions': [{'name': 'prostaglandin I2 analogue', 'type': 'DRUG', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jongwon Ha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jongwon Ha', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}