Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT00268567
Status:
COMPLETED
Last Update Posted:
2005-12-22
First Post:
2005-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-10', 'lastUpdateSubmitDate': '2005-12-21', 'studyFirstSubmitDate': '2005-12-21', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission of renal disease at 6 months'}], 'secondaryOutcomes': [{'measure': 'partial remission at 6 months and adverse events'}]}, 'conditionsModule': {'conditions': ['Nephritis, Lupus']}, 'descriptionModule': {'briefSummary': 'lupus nephritis accounts for the most morbidity and mortality in patients with SLE. Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years. However, some patients do not respond well to the regimen, and adverse effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a few pilot observational studies and reports suggesting leflunomide was also safe, well-tolerated and may be effective in SLE patients without important organ involvement. It has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were diagnosed as SLE according to the updated criteria of American College of Rheumatology in 1997, had a systemic lupus erythematosus disease activity index (SLEDAI)equal or greater than 8; had evident renal diseases and biopsy-documented diffuse proliferative or focal proliferative lupus nephritis, with or without coincident membranous nephropathy, and pathological activity index (AI)equal or greater than 4\n\nExclusion Criteria:\n\n* Patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.'}, 'identificationModule': {'nctId': 'NCT00268567', 'briefTitle': 'Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy', 'orgStudyIdInfo': {'id': 'CLLNT-2002HL0133'}}, 'armsInterventionsModule': {'interventions': [{'name': 'leflunomide combined with prednisone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Renal Division, Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Division of Nephrology, Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Renal Division, the First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Harbin', 'country': 'China', 'facility': 'Department of Rheumatology, the Second Affiliated Hospital, Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Department of Nephrology, Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Renal Division, Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Renal Division, Renji Hospital, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Haiyan Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Nephrology, Peking University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}}}}