Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT00777933
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2008-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-21', 'studyFirstSubmitDate': '2008-10-21', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft survival', 'timeFrame': '5 years'}, {'measure': 'Patient survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'cumulative incidence of acute rejection', 'timeFrame': '5 years'}, {'measure': 'estimated glomerular filtration rate', 'timeFrame': '5 year'}, {'measure': 'new-onset diabetes mellitus', 'timeFrame': '5 year'}, {'measure': 'Hypertension', 'timeFrame': '5 year'}, {'measure': 'hyperlipidemia', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'Living Donors']}, 'referencesModule': {'references': [{'pmid': '19744223', 'type': 'DERIVED', 'citation': 'Lee YJ, Kim B, Lee JE, Kim YG, Kim DJ, Kim SJ, Joh JW, Oh HY, Huh W. Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up. Transpl Int. 2010 Feb;23(2):147-54. doi: 10.1111/j.1432-2277.2009.00955.x. Epub 2009 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.', 'detailedDescription': '131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level \\< 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 15 years\n* first living donor kidney transplantation\n\nExclusion Criteria:\n\n* congestive heart failure (ejection fraction \\< 35%)\n* chronic liver disease\n* underlying diabetes mellitus\n* evidence of systemic infection at screening time\n* history of malignant disease\n* multiple organ transplantation\n* positive serologic evidence of human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT00777933', 'briefTitle': 'Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation', 'orgStudyIdInfo': {'id': '2000-07-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'cyclosporine', 'interventionNames': ['Drug: cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'Tacrolimus', 'interventionNames': ['Drug: tacrolimus']}], 'interventions': [{'name': 'tacrolimus', 'type': 'DRUG', 'armGroupLabels': ['Tacrolimus']}, {'name': 'cyclosporine', 'type': 'DRUG', 'armGroupLabels': ['cyclosporine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Transplantation Center, Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Won Joh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Won Joh', 'oldOrganization': 'Samsung Medical Center'}}}}