Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01799460
Status:
UNKNOWN
Last Update Posted:
2013-04-23
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-10', 'releaseDate': '2016-01-13'}, {'resetDate': '2024-01-19', 'releaseDate': '2023-04-30'}], 'estimatedResultsFirstSubmitDate': '2016-01-13'}}, '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': 'D005938', 'term': 'Glucocorticoids'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-02-23', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach', 'timeFrame': 'one year', 'description': 'Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['single-nucleotide-polymorphism', 'Traditional Chinese Medicine', 'the Comprehensive Treatment Regimen'], 'conditions': ['Idiopathic Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.', 'detailedDescription': 'The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'idiopathic membranous nephropathy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic membranous nephropathy\n* Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g\n* Voluntarily participated in the study and signed an informed consent\n\nExclusion Criteria:\n\n* Combined life-threatening complications such as serious infection\n* Abnormal glucose metabolism\n* Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc\n* Pregnancy or breast-feeding women\n* Undergoing other clinical trials'}, 'identificationModule': {'nctId': 'NCT01799460', 'briefTitle': 'Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies', 'orgStudyIdInfo': {'id': 'ShanghaiMEC-2011'}, 'secondaryIdInfos': [{'id': '11YZ65', 'type': 'OTHER_GRANT', 'domain': 'Shanghai Municipal Education Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CR/CTR group', 'description': 'The complete remission group treated by the Comprehensive Treatment Regimen', 'interventionNames': ['Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine']}, {'label': 'NR/CTR group', 'description': 'The non-remission group treated by the Comprehensive Treatment Regimen', 'interventionNames': ['Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine']}, {'label': 'CR/IA group', 'description': 'The complete remission group treated by Immunosuppressive Agents', 'interventionNames': ['Drug: The immunosuppressive agents']}, {'label': 'NR/IA group', 'description': 'The non-remission group treated by Immunosuppressive Agents.', 'interventionNames': ['Drug: The immunosuppressive agents']}], 'interventions': [{'name': 'The Comprehensive Treatment Regimen of Traditional Chinese Medicine', 'type': 'DRUG', 'otherNames': ['ShenQiMoShen Decoction', 'HuoXueTongMai Capsule', 'HeiLiaoDou Particle'], 'description': '①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day\n\n②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily.\n\n③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.', 'armGroupLabels': ['CR/CTR group', 'NR/CTR group']}, {'name': 'The immunosuppressive agents', 'type': 'DRUG', 'otherNames': ['Glucocorticoid', 'Cyclosporine', 'Cyclophosphamide', 'Tacrolimus'], 'description': 'According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis', 'armGroupLabels': ['CR/IA group', 'NR/IA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Lin, PHD', 'role': 'CONTACT', 'email': 'happytlynn@163.com', 'phone': '86-13816583673'}], 'facility': 'Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wang Lin, PHD', 'role': 'CONTACT', 'email': 'happytlynn@163.com', 'phone': '86-13816583673'}], 'overallOfficials': [{'name': 'Wang Lin, PHD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-01-13', 'type': 'RELEASE'}, {'date': '2016-02-10', 'type': 'RESET'}, {'date': '2023-04-30', 'type': 'RELEASE'}, {'date': '2024-01-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanghai University of Traditional Chinese Medicine'}}}}