NCT01056835已完成3 期
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- graft pathology, serum creatinine, creatinine clearance, eGFR
研究概览
简要总结
The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prevalent renal transplant recipients 2 years after transplantation
- •no history of acute rejection
- •stable renal function
排除标准
- •history of biopsy-proven chronic allograft nephropathy
- •history of biopsy-proven CNI nephrotoxicity
- •history of biopsy-proven or clinical acute rejection
- •unstable trough level of CNI or extremely low level of CNI
- •bleeding tendency(+)
- •pregnancy or pregnant-willing
- •anticoagulation(+)
- •antiplatelet agent (+)
- •significant comorbidity(+): Acute coronary syndrome, pneumonia
研究组 & 干预措施
control
No Intervention
干预措施: prostaglandin I2 analogue (Drug)
结局指标
主要结局
graft pathology, serum creatinine, creatinine clearance, eGFR
时间窗: 1 year after drug administration
次要结局
未报告次要终点
研究者
Jongwon Ha
Professor
Seoul National University Hospital
研究点 (1)
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