Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-06 @ 2:49 PM
Study NCT ID:
NCT03791827
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2018-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Registry of Pediatric Lupus Nephritis in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], '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': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2018-12-24', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission', 'timeFrame': '5 years', 'description': 'complete remission is defined as UPC\\<0.2 mg/mg， or 24-hour urine protein\\<150mg with normal kidney function and without hematuria'}, {'measure': 'Partial remission', 'timeFrame': '5 years', 'description': 'Partial remission is defined as non-nephrotic range proteinura, decrease of urine protein ≥50%， and serum creatinine remains stable (±25% of baseline) or is improved but not normal yet'}], 'secondaryOutcomes': [{'measure': 'End stage renal disease (ESRD)', 'timeFrame': '1 year, 2 years, 3 years, 4 years and 5 years', 'description': 'ESRD is defined as eGFR\\<15ml/1.73m2, initiation of long-term dialysis or kidney'}, {'measure': 'Mortality', 'timeFrame': '1 year, 2 years, 3 years, 4 years and 5 years', 'description': 'Death of patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis', 'Children', 'Steroid', 'Immunosuppressive Treatment']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 1200 pediatric lupus nephritis patients younger than 18 years old will be enrolled from more than 35 pediatric nephrology medical centers nationwide', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDiagnosis of lupus nephritis:\n\n* Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus\n* Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein\\>150mg, or UPC\\>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte\\>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis\n* The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003\n\nExclusion Criteria (either of the following criteria):\n\n* Complicated with other systemic diseases, including basic diseases with clinical significance\n* Patients with tumors\n* Patients with abnormal glucose metabolism\n* Immunodeficiency patients\n* Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment\n* Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.)\n* Drug-induced lupus, congenital lupus and other secondary lupus\n* Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)"}, 'identificationModule': {'nctId': 'NCT03791827', 'briefTitle': 'Multicenter Registry of Pediatric Lupus Nephritis in China', 'organization': {'class': 'OTHER', 'fullName': 'Second Xiangya Hospital of Central South University'}, 'officialTitle': 'Multicenter Registry of Pediatric Lupus Nephritis in China', 'orgStudyIdInfo': {'id': 'Pediatric lupus nephritis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Corticosteroid', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine']}, {'label': 'Corticosteroid and cyclophosphamide', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Cyclophosphamide']}, {'label': 'Corticosteroid and mycophenolate mofetil', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Mycophenolate Mofetil']}, {'label': 'Corticosteroid and azathioprine', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Azathioprine']}, {'label': 'Corticosteroid and tacrolimus', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Tacrolimus']}, {'label': 'Corticosteroid and cyclosporine A', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Cyclosporine A']}, {'label': 'Corticosteroid, mycophenolate mofetil and tacrolimus', 'description': 'Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus', 'interventionNames': ['Drug: Corticosteroid', 'Drug: Hydroxychloroquine', 'Drug: Azathioprine', 'Drug: Cyclosporine A']}, {'label': 'Retuximab', 'description': 'An option for refractory lupus nephritis', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Corticosteroid', 'type': 'DRUG', 'otherNames': ['Steroid', 'Prednisone', 'Methylprednisone', 'Prednisolone'], 'description': 'corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.', 'armGroupLabels': ['Corticosteroid', 'Corticosteroid and azathioprine', 'Corticosteroid and cyclophosphamide', 'Corticosteroid and cyclosporine A', 'Corticosteroid and mycophenolate mofetil', 'Corticosteroid and tacrolimus', 'Corticosteroid, mycophenolate mofetil and tacrolimus']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine is recommended as the basic therapy for lupus nephritis', 'armGroupLabels': ['Corticosteroid', 'Corticosteroid and azathioprine', 'Corticosteroid and cyclophosphamide', 'Corticosteroid and cyclosporine A', 'Corticosteroid and mycophenolate mofetil', 'Corticosteroid and tacrolimus', 'Corticosteroid, mycophenolate mofetil and tacrolimus']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.', 'armGroupLabels': ['Corticosteroid and cyclophosphamide']}, {'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'description': 'The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d', 'armGroupLabels': ['Corticosteroid and mycophenolate mofetil']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'The recommended dose of azathioprine is 1.5 to 2mg/kg/d', 'armGroupLabels': ['Corticosteroid and azathioprine', 'Corticosteroid, mycophenolate mofetil and tacrolimus']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h', 'armGroupLabels': ['Corticosteroid and tacrolimus']}, {'name': 'Cyclosporine A', 'type': 'DRUG', 'description': 'The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h', 'armGroupLabels': ['Corticosteroid and cyclosporine A', 'Corticosteroid, mycophenolate mofetil and tacrolimus']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['anti-CD20 antibody'], 'description': 'The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses', 'armGroupLabels': ['Retuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tian Shen, M.D.', 'role': 'CONTACT', 'email': 'shentian0215@csu.edu.cn', 'phone': '+8613548764640'}], 'facility': 'The Second Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Xiqiang Dang, M.D.', 'role': 'CONTACT', 'email': 'dangxiqiang@csu.edu.cn', 'phone': '8613739052618'}, {'name': 'Tian Shen, M.D', 'role': 'CONTACT', 'email': 'shentian0215@csu.edu.cn', 'phone': '8613548764640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, IPD is not available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiqiang Dang', 'class': 'OTHER'}, 'collaborators': [{'name': "The Children's Hospital Affiliated to Suzhou University", 'class': 'UNKNOWN'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Inner Mongolia Medical College', 'class': 'UNKNOWN'}, {'name': "People's Hospital of Zhangjiajie", 'class': 'UNKNOWN'}, {'name': 'Puyang Oilfield General Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Guizhou Maternal and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': "The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University", 'class': 'UNKNOWN'}, {'name': "Shenzhen Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': "Yichang Central People's Hospital", 'class': 'OTHER'}, {'name': "Xian Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "The First People's Hospital of Yunnan", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xinxiang Medical College', 'class': 'OTHER'}, {'name': "Shanxi Provincial Maternity and Children's Hospital", 'class': 'OTHER'}, {'name': "Liaocheng People's Hospital", 'class': 'OTHER'}, {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Children's Hospital of Hebei Province", 'class': 'OTHER'}, {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': "Zhengzhou Children's Hospital", 'class': 'UNKNOWN'}, {'name': "The Children's Hospital of Chongqing Medical University", 'class': 'UNKNOWN'}, {'name': "Wuxi Women's & Children's Hospital", 'class': 'OTHER'}, {'name': "The Children's Hospital of Fudan University", 'class': 'UNKNOWN'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': "Qilu Children's Hospital of Shandong University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiqiang Dang', 'investigatorAffiliation': 'Second Xiangya Hospital of Central South University'}}}}