Children, Immunosuppressive Treatment, Lupus Nephritis, Steroid
Conditions
Brief summary
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.
Interventions
DRUGCorticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
DRUGHydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
DRUGCyclophosphamide
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.
DRUGMycophenolate Mofetil
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
DRUGAzathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
DRUGTacrolimus
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
DRUGCyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
DRUGRituximab
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
Sponsors
The Children's Hospital Affiliated to Suzhou University
Shandong Provincial Hospital
Guizhou Provincial People's Hospital
LanZhou University
The First Affiliated Hospital of Inner Mongolia Medical College
People's Hospital of Zhangjiajie
Puyang Oilfield General Hospital
The First Affiliated Hospital of Anhui Medical University
Guizhou Maternal and Child Health Care Hospital
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University
Shenzhen Children's Hospital
The Second Affiliated Hospital of Harbin Medical University
Yichang Central People's Hospital
Xian Children's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First People's Hospital of Yunnan
The First Affiliated Hospital of Xiamen University
The First Affiliated Hospital of Xinxiang Medical College
Shanxi Provincial Maternity and Children's Hospital
Liaocheng People's Hospital
Fujian Provincial Hospital
First Affiliated Hospital of Guangxi Medical University
Lanzhou University Second Hospital
Guangzhou First People's Hospital
The Second Hospital of Shandong University
Children's Hospital of Hebei Province
Beijing Children's Hospital
Zhengzhou Children's Hospital
The Children's Hospital of Chongqing Medical University
Wuxi Women's & Children's Hospital
The Children's Hospital of Fudan University
Shanghai Children's Medical Center
Qilu Children's Hospital of Shandong University
Xiqiang Dang
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of lupus nephritis: * 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
(either of the following criteria): * Complicated with other systemic diseases, including basic diseases with clinical significance * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission | 5 years | complete remission is defined as UPC\<0.2 mg/mg， or 24-hour urine protein\<150mg with normal kidney function and without hematuria |
| Partial remission | 5 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End stage renal disease (ESRD) | 1 year, 2 years, 3 years, 4 years and 5 years | ESRD is defined as eGFR\<15ml/1.73m2, initiation of long-term dialysis or kidney |
| Mortality | 1 year, 2 years, 3 years, 4 years and 5 years | Death of patients |
Countries
China
Contacts
Primary ContactXiqiang Dang, M.D.
Backup ContactTian Shen, M.D
Outcome results
None listed