Registry of IgA Nephropathy in Chinese Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Improvement of proteinuria
研究概览
简要总结
This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.
详细描述
A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.
- Establishment of registration database online.
- Participants will be enrolled according to the inclusion criteria and exclusion criteria.
- The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
- SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary IgA nephropathy.
- •Presenting with nephrotic proteinuria, defined as 24-hour urinary protein>50mg/kg, or UPC>2.0 mg/mg.
- •Informed consent must be signed.
排除标准
- •Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
研究组 & 干预措施
corticosteroid
pediatric IgA nephropathy treated with only corticosteroid
干预措施: ACE Inhibitor or Angiotensin receptor antagonist (Drug)
corticosteroid
pediatric IgA nephropathy treated with only corticosteroid
干预措施: Corticosteroid (Drug)
corticosteroid
pediatric IgA nephropathy treated with only corticosteroid
干预措施: Dipyridamole (Drug)
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
干预措施: Corticosteroid (Drug)
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
干预措施: Cyclophosphamide (Drug)
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
干预措施: Dipyridamole (Drug)
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
干预措施: ACE Inhibitor or Angiotensin receptor antagonist (Drug)
corticosteroid and mycophenolate mofetil
pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
干预措施: Corticosteroid (Drug)
corticosteroid and mycophenolate mofetil
pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
干预措施: Mycophenolate mofetil (Drug)
corticosteroid and mycophenolate mofetil
pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
干预措施: Dipyridamole (Drug)
corticosteroid and mycophenolate mofetil
pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
干预措施: ACE Inhibitor or Angiotensin receptor antagonist (Drug)
结局指标
主要结局
Improvement of proteinuria
时间窗: Two years
Complete remission is defined as 24-hour urine protein\<150mg or UPC\<0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function.
Hypertension
时间窗: Two years
Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.
Renal dysfunction
时间窗: Two years
Renal dysfunction is defined as eGFR declined by more than 50%.
次要结局
- End stage renal disease(ESRD)(Two years)
- Mortality(Two years)
研究者
Jie Ding
Prof.
Peking University First Hospital