Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT01328834
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2011-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate (complete or partial remission)', 'timeFrame': '6 months after therapy'}], 'secondaryOutcomes': [{'measure': 'The changes of proteinuria', 'timeFrame': 'every 3 months up to 6 months'}, {'measure': 'SLEDAI scores', 'timeFrame': 'every 3 months up to 6 months', 'description': 'SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992).'}, {'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'every 3 months up to 6 months', 'description': 'Adverse events, including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.'}, {'measure': 'The changes of renal function', 'timeFrame': 'every 3 months up to 6 months'}, {'measure': 'Relapse', 'timeFrame': 'every 3 months up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nephritis, Lupus', 'Tacrolimus'], 'conditions': ['Nephritis, Lupus']}, 'descriptionModule': {'briefSummary': 'This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of either sex, 14-65 years of age;\n2. Diagnosis of SLE according to the ACR criteria (1997);\n3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;\n4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;\n5. proteinuria \\> 1g/24hr or Scr \\> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \\> 5 WBC/high power field (hpf) (excluding infection), \\> 5 RBC/hpf);\n6. Provision of written informed consent by subject or guardian\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide written informed consent ;\n2. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;\n3. Scr \\> 4mg/dl (354umol/L);\n4. Needing pulse intravenous MP or intravenous immunoglobulin;\n5. Lupus encephalopathy;\n6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);\n7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;\n8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids\n9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;\n10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;\n11. Pregnancy, nursing or use of a non-reliable method of contraception.'}, 'identificationModule': {'nctId': 'NCT01328834', 'briefTitle': 'Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'orgStudyIdInfo': {'id': 'SYSU-PRGLN-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADVAGRAF', 'description': 'Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase', 'interventionNames': ['Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)']}], 'interventions': [{'name': 'Tacrolimus Sustained-release Capsules (ADVAGRAF)', 'type': 'DRUG', 'otherNames': ['ADVAGRAF: Tacrolimus Sustained-release Capsules'], 'description': 'Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.', 'armGroupLabels': ['ADVAGRAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University IRB', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yu Xueqing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xueqing Yu', 'oldOrganization': 'Sun Yat-sen University'}}}}