NCT00302510已完成不适用
Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein
Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2000年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
详细描述
Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi and lipid abnormalities, particularly with an elevated level of plasma apoprotein E (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine protein and reduction of lipoprotein thrombi on repeated renal biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
- •Age 15~60 years, sex free
排除标准
- •Serum creatinine > 500 umol/l
- •Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
- •Congenital or acquired immunodeficiency
- •Patients with severe infection or central nervous system symptoms
- •Immediately life-threatening organ manifestations (e.g. lung haemorrhage or massive gastro-intestinal bleeding, heart failure due to pericarditis or myocarditis, liver dysfunction measured on at least 2 separate occasion)
结局指标
主要结局
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
时间窗: 3 months
次要结局
- To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.(3 months)
研究者
研究点 (1)
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