MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- microRNA profiles
研究概览
简要总结
The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.
详细描述
The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent to participate in the study
- •Actual eGFR > 20-25 ml/min/1.73 m2
排除标准
- •Multi-organ transplantation
- •Pregnancy
- •ABO incompatible blood group
- •Second, third, fouth kidney transplantation
- •HIV positive, active or carrier in any infections
研究组 & 干预措施
Everolimus
everolimus dosing to tough level 6-10 ng/ml
干预措施: Everolimus (Drug)
Tacrolimus
Tacrolimus dosing to target tough level 5-10 ng/ml
干预措施: Tacrolimus (Drug)
结局指标
主要结局
microRNA profiles
时间窗: 5 years
microRNA profiles including rejection and nephrotoxicity markers
次要结局
- Allograft tissue pathology(At year 2 and 5)
研究者
Wiwat Chancharoenthana
Dr.
Chulalongkorn University