Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT00615667
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2008-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'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': 'D009401', 'term': 'Nephrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2008-02-01', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate', 'timeFrame': '2006-2008'}], 'secondaryOutcomes': [{'measure': 'Renal function, proteinuria, relapse', 'timeFrame': '2006-2008'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Refractory Nephrotic syndrome', 'Tacrolimus'], 'conditions': ['Kidney Diseases', 'Nephrotic Syndrome', 'Tacrolimus']}, 'descriptionModule': {'briefSummary': 'Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.'}, '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 Nephrotic syndrome with hypoalbuminemia (\\<3.0g/dl) and heavy proteinuria (\\> 3.5g/24hr);\n3. Provision of written informed consent by subject or guardian;\n4. Refractory nephrotic syndrome:\n\nSteroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide written informed consent ;\n2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;\n3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;\n4. Pregnancy, nursing or use of a non-reliable method of contraception;\n5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;\n6. Previous kidney transplant or planted transplant;\n7. Scr \\> 4mg/dl (353umol/L);\n8. Active hepatitis, with liver dysfunction;\n9. Diagnosed DM;\n10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .'}, 'identificationModule': {'nctId': 'NCT00615667', 'briefTitle': 'Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'orgStudyIdInfo': {'id': 'SYSU-PRGNS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tacrolimus(fk506) treatment', 'description': 'tacrolimus(fk506) treatment', 'interventionNames': ['Drug: tacrolimus (FK506)']}], 'interventions': [{'name': 'tacrolimus (FK506)', 'type': 'DRUG', 'description': 'Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;', 'armGroupLabels': ['tacrolimus(fk506) treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xueqing Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Ping Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, West China Hospital of Sichuan University'}, {'name': 'Yunhua Liao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University'}, {'name': 'Jin li Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of nephrology, People's Hospital of Yunnan Province"}, {'name': 'Jian Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Fuzhou Military General Hospital'}, {'name': 'Tanqi Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University'}, {'name': 'Yaozhong Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology, 1st People's Hospital of Foshan"}, {'name': 'Junzhou Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology,1st People's Hospital of Guangzhou"}, {'name': 'Wei Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology, People's Hospital Guangdong Provincial"}, {'name': 'Zhengrong Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Nanfang Hospital of Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xue Qing Yu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}