Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-04 @ 5:20 PM
Study NCT ID:
NCT02115659
Status:
UNKNOWN
Last Update Posted:
2014-04-17
First Post:
2014-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal volume measured by high resolution magnetic resolution imaging', 'timeFrame': '2 yrs'}], 'secondaryOutcomes': [{'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': '2 yrs'}, {'measure': 'Adverse events.', 'timeFrame': '2 yrs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADPKD', 'triptolide'], 'conditions': ['Autosomal Dominant Polycystic Kidney Disease (ADPKD)']}, 'descriptionModule': {'briefSummary': 'Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.', 'detailedDescription': 'Randomized Controlled Trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADPKD patient older then 40 years of age without gender limitation\n* Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2\n* documented kidney volume progression with yearly increasing rate more than 6%\n* informed consent\n\nExclusion Criteria:\n\n* Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception\n* impaired liver function as increased liver enzymes (2-fold above normal values)\n* uncontrolled hypercholesterolemia (fasting cholesterol \\> 8 mmol/l) or hypertriglyceridaemia (\\> 5 mmol/l) under lipid lowering therapy\n* granulocytopenia (white blood cell \\< 3,000/mm3) or thrombocytopenia (platelets \\< 100,000/mm3)\n* hepatitis B or C, HIV infection\n* malignancy\n* mental illness that interfere with the patient ability to comply with the protocol\n* drug or alcohol abuse\n* known hypersensitivity to similar drugs as Triptolide-Containing Formulation'}, 'identificationModule': {'nctId': 'NCT02115659', 'briefTitle': 'Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'orgStudyIdInfo': {'id': 'CZKIPLA-ADPKD-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Triptolide-Containing Formulation', 'description': 'Triptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring.', 'interventionNames': ['Drug: Triptolide-Containing Formulation']}], 'interventions': [{'name': 'Triptolide-Containing Formulation', 'type': 'DRUG', 'otherNames': ['Triptolide-Containing Formulation plus standard treatment.'], 'description': 'Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.', 'armGroupLabels': ['Triptolide-Containing Formulation']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo plus standard treatment.'], 'description': 'Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200003', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changlin Mei, MD', 'role': 'CONTACT', 'email': 'chlmei1954@126.com'}, {'name': 'Changlin Mei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Changlin Mei, MD', 'role': 'CONTACT', 'email': 'chlmei1954@126.com'}], 'overallOfficials': [{'name': 'Changlin Mei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor,Director of the Kidney Institute', 'investigatorFullName': 'Mei changlin', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}