The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Renal function
研究概览
简要总结
The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.
详细描述
The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All kidney transplant recipients underwent transplantation at Chulalongkorn University
排除标准
- •Pregnancy
- •Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
- •Non-cooperated recipients
研究组 & 干预措施
Non-biopsy
Population in this arm will be adjusted immunosuppressive drug only from the result of tough level.
Protocol biopsy
Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level.
干预措施: Surveillance protocol kidney allograft biopsy (Procedure)
结局指标
主要结局
Renal function
时间窗: 24 months
24 h-CrCl
次要结局
- Renal pathology(24 months)
- Complications(immediate, 1 month)
研究者
Wiwat Chancharoenthana
Chulalongkorn University
Chulalongkorn University