Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:40 PM
Study NCT ID:
NCT00801268
Status:
TERMINATED
Last Update Posted:
2015-03-30
First Post:
2008-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}], 'ancestors': [{'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004642', 'term': 'Emodin'}], 'ancestors': [{'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'whyStopped': 'high rate of drop-out', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-27', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI calculated kidney volume, eGFR', 'timeFrame': 'Every 3-6months'}], 'secondaryOutcomes': [{'measure': 'End-stage kidney disease (ESRD)', 'timeFrame': 'every 2months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['polycystic kidney disease', 'tripterygium wilfordii'], 'conditions': ['Polycystic Kidney']}, 'descriptionModule': {'briefSummary': 'Triptolide has been approve effective in animal model.', 'detailedDescription': 'Randomized'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically established ADPKD\n* eGFR\\>30ml/min.\n* Chinese nationality\n\nExclusion Criteria:\n\n* Uncontrolled infections\n* Non-ADPKD complications'}, 'identificationModule': {'nctId': 'NCT00801268', 'briefTitle': 'Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'orgStudyIdInfo': {'id': 'NJCT-0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'emodin', 'interventionNames': ['Drug: Emodin']}, {'type': 'EXPERIMENTAL', 'label': 'Triptolide Woldifii', 'description': 'TW60mg/d', 'interventionNames': ['Drug: tripterygium wilfordii']}], 'interventions': [{'name': 'tripterygium wilfordii', 'type': 'DRUG', 'description': 'TW，60mg/d', 'armGroupLabels': ['Triptolide Woldifii']}, {'name': 'Emodin', 'type': 'DRUG', 'otherNames': ['Frangula emodin,Frangulic acid'], 'description': '100mg/d', 'armGroupLabels': ['emodin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Liu ZH, Yao XD,Chen X,Hu YL', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Yao Xiaodan', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Liu Zhihong, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute of Nephrology, Jinling Hospital'}]}, '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'}}}}