NCT01052259终止不适用
Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Histopathological findings by Banff criteria
研究概览
简要总结
The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.
详细描述
The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.
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
- 11 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic rejection defined by Banff 2007 criteria
排除标准
- •Patients who have recurrent renal diseases and virus-associated renal diseases
- •Patients who have initial WBC < 4,000, neutrophil < 1,000 , platelet < 50,000 or Hb < 8g
- •Patients who have acute or chronic infection
研究组 & 干预措施
Deoxyspergualin, Treatment,
Experimental
干预措施: Deoxyspergualin (Drug)
结局指标
主要结局
Histopathological findings by Banff criteria
时间窗: 6 month after treatment initiation
次要结局
- Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)(6 and 12 months after treatment initiation)
研究者
研究点 (8)
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