Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-05 @ 5:39 PM
Study NCT ID:
NCT01161459
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2010-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-29', 'studyFirstSubmitDate': '2010-07-12', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid', 'timeFrame': '18 months', 'description': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Idiopathic Membranous Nephropathy', 'Treatment', 'FK506', 'Tripterygium wilfordii'], 'conditions': ['Idiopathic Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.\n\nTo investigate the safety and tolerability of Tripterygium wilfordii plus steroid', 'detailedDescription': "Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin\\>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Biopsy-proven idiopathic membranous nephropathy\n2. Nephrotic syndrome with proteinuria ( \\> 3.5 g/day) and serum albumin \\< 30 g/dl\n3. Age 18-65 years with informed consent\n\nExclusion Criteria:\n\n1. Patient with elevated serum creatinine concentration\n2. Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days\n3. Active/serious infection\n4. Patient with hepatitis B surface antigen or who is hepatitis C antibody positive\n5. Patient who is diabetic\n6. Patient is allergic or intolerant to macrolide antibiotics or tacrolimus'}, 'identificationModule': {'nctId': 'NCT01161459', 'briefTitle': 'Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'Research Institute of Nephrology, Jinling Hospital', 'orgStudyIdInfo': {'id': 'NJCT-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tripterygium wilfordii', 'description': '120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months', 'interventionNames': ['Drug: Tripterygium wilfordii']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FK506', 'interventionNames': ['Drug: FK506']}], 'interventions': [{'name': 'Tripterygium wilfordii', 'type': 'DRUG', 'otherNames': ['TW'], 'description': 'Tripterygium wilfordii 120mg/d Prednisone 30mg/d', 'armGroupLabels': ['Tripterygium wilfordii']}, {'name': 'FK506', 'type': 'DRUG', 'otherNames': ['Tacrolimus + Prednisone 30mg/d'], 'description': 'capsule', 'armGroupLabels': ['FK506']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Zhihong Liu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhi-Hong Liu, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zhi-Hong Liu, M.D.', 'investigatorAffiliation': 'Nanjing University School of Medicine'}}}}