A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- the renal recovery rate
研究概览
简要总结
The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
详细描述
This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference
- •serum positive ANCA and the ANCA level ≥100 relative unit/ml
- •with renal involvement and serum creatinine≥3 mg/dl
- •written informed consent had been provided.
排除标准
- •other secondary vasculitis
- •anti-glomerular basement membrane(GBM) positive
- •severe infection; hepatitis B antigenemia, anti- hepatitis C virus
- •immunodeficiency; or immunoglobulin G(IgG)<2g/l
- •life threatening
- •renal biopsy show globally sclerotic glomeruli>60% and normal glomeruli<10%
- •need renal replacement therapy for more than 4w
- •received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.
研究组 & 干预措施
DFPP&CTX
double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX)
干预措施: DFPP&CTX (Other)
cyclophosphamide
cyclophosphamide(CTX) pulse therapy
干预措施: CTX (Drug)
结局指标
主要结局
the renal recovery rate
时间窗: 3 months
the renal recovery rate at 3 mo defined by dialysis independence and the SCr \<5mg/dl for the patients needed renal replacement therapy at the basement, or the SCr decreased more than 30% of the baseline and the urine sediment red blood cell less than 50\*104/ml for the patients without renal replacement at the basement.
次要结局
- kidney survival(12 months)
研究者
Zhi-Hong Liu, M.D.
Professor
Nanjing University School of Medicine