Multicenter Registry of Pediatric Lupus Nephritis in China
NCT ID: NCT03791827
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2018-12-01
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Corticosteroid
Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Corticosteroid and cyclophosphamide
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Cyclophosphamide
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.
Corticosteroid and mycophenolate mofetil
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Mycophenolate Mofetil
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
Corticosteroid and azathioprine
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
Corticosteroid and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Tacrolimus
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
Corticosteroid and cyclosporine A
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
Retuximab
An option for refractory lupus nephritis
Rituximab
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
Interventions
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Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Cyclophosphamide
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.
Mycophenolate Mofetil
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
Tacrolimus
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
Rituximab
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
* 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
* The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003
Exclusion Criteria
* Patients with tumors
* Patients with abnormal glucose metabolism
* Immunodeficiency patients
* Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment
* Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.)
* Drug-induced lupus, congenital lupus and other secondary lupus
* Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)
18 Years
ALL
No
Sponsors
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The Children's Hospital Affiliated to Suzhou University
UNKNOWN
Shandong Provincial Hospital
OTHER_GOV
Guizhou Provincial People's Hospital
OTHER
LanZhou University
OTHER
The First Affiliated Hospital of Inner Mongolia Medical College
UNKNOWN
People's Hospital of Zhangjiajie
UNKNOWN
Puyang Oilfield General Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Guizhou Maternal and Child Health Care Hospital
UNKNOWN
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University
UNKNOWN
Shenzhen Children's Hospital
OTHER_GOV
The Second Affiliated Hospital of Harbin Medical University
OTHER
Yichang Central People's Hospital
OTHER
Xian Children's Hospital
OTHER_GOV
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The First People's Hospital of Yunnan
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
The First Affiliated Hospital of Xinxiang Medical College
OTHER
Shanxi Provincial Maternity and Children's Hospital
OTHER
Liaocheng People's Hospital
OTHER
Fujian Provincial Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Lanzhou University Second Hospital
OTHER
Guangzhou First People's Hospital
OTHER
The Second Hospital of Shandong University
OTHER
Children's Hospital of Hebei Province
OTHER
Beijing Children's Hospital
OTHER
Zhengzhou Children's Hospital
UNKNOWN
The Children's Hospital of Chongqing Medical University
UNKNOWN
Wuxi Women's & Children's Hospital
OTHER
The Children's Hospital of Fudan University
UNKNOWN
Shanghai Children's Medical Center
OTHER
Qilu Children's Hospital of Shandong University
OTHER
Xiqiang Dang
OTHER
Responsible Party
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Xiqiang Dang
Professor
Locations
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The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pediatric lupus nephritis
Identifier Type: -
Identifier Source: org_study_id
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