NCT02057523终止4 期
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- 50% Reduction in Proteinuria or Proteinuria < 150mg/Day
研究概览
简要总结
The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.
- •Failed standard therapy (>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression
排除标准
- 未提供
研究组 & 干预措施
Acthar
Experimental
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
干预措施: Acthar (Drug)
结局指标
主要结局
50% Reduction in Proteinuria or Proteinuria < 150mg/Day
时间窗: 6 months
次要结局
- 25% Improvement in the MDRD eGFR(6 months)
研究者
Sanjeev Akkina
Assistant Professor
University of Illinois at Chicago
研究点 (1)
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