Multicenter Registry of Pediatric Lupus Nephritis in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Complete remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
Corticosteroid
Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
干预措施: Hydroxychloroquine (Drug)
Corticosteroid
Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
干预措施: Corticosteroid (Drug)
Corticosteroid and cyclophosphamide
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
干预措施: Corticosteroid (Drug)
Corticosteroid and cyclophosphamide
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
干预措施: Hydroxychloroquine (Drug)
Corticosteroid and cyclophosphamide
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
干预措施: Cyclophosphamide (Drug)
Corticosteroid and mycophenolate mofetil
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
干预措施: Corticosteroid (Drug)
Corticosteroid and mycophenolate mofetil
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
干预措施: Hydroxychloroquine (Drug)
Corticosteroid and mycophenolate mofetil
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
干预措施: Mycophenolate Mofetil (Drug)
Corticosteroid and azathioprine
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
干预措施: Corticosteroid (Drug)
Corticosteroid and azathioprine
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
干预措施: Hydroxychloroquine (Drug)
Corticosteroid and azathioprine
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
干预措施: Azathioprine (Drug)
Corticosteroid and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
干预措施: Corticosteroid (Drug)
Corticosteroid and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
干预措施: Hydroxychloroquine (Drug)
Corticosteroid and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
干预措施: Tacrolimus (Drug)
Corticosteroid and cyclosporine A
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
干预措施: Corticosteroid (Drug)
Corticosteroid and cyclosporine A
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
干预措施: Hydroxychloroquine (Drug)
Corticosteroid and cyclosporine A
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
干预措施: Cyclosporine A (Drug)
Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
干预措施: Corticosteroid (Drug)
Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
干预措施: Hydroxychloroquine (Drug)
Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
干预措施: Azathioprine (Drug)
Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
干预措施: Cyclosporine A (Drug)
Retuximab
An option for refractory lupus nephritis
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete remission
时间窗: 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
时间窗: 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
次要结局
- End stage renal disease (ESRD)(1 year, 2 years, 3 years, 4 years and 5 years)
- Mortality(1 year, 2 years, 3 years, 4 years and 5 years)
研究者
Xiqiang Dang
Professor
Second Xiangya Hospital of Central South University