The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Plasma BK viral load change
研究概览
简要总结
BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients at King Chulalongkorn Memorial Hospital
- •age >= 18 years
- •persistent BK viremia >1000 copies/mL at least 2 times in 3 weeks or single time > 10000 copies/mL
排除标准
- •BK VL >10^5 log
- •Previous BKVAN treatment
- •Drug hypersensitivity to mTORi or leflunomide
研究组 & 干预措施
reduced-dose tacrolimus and Leflunomide
Patient will receive tacrolimus with target concentration of 3-6 ng/mL with leflunomide 100 mg/day loading dose for 5 days, followed by 40 mg/day thereafter. Duration for this regimen would be at least 3 months.
干预措施: reduced dose tacrolimus and Leflunomide (Drug)
mTORi with reduced-dose tacrolimus
Patient will received everolimus with target trough concentration of 3-6 ng/mL and tacrolimus with target trough concentration of 2-4 ng/mL. Duration for this regimen would be at least 3 months.
干预措施: Everolimus (Drug)
结局指标
主要结局
Plasma BK viral load change
时间窗: 3 months
3-month plasma BK viral load change from randomization
次要结局
- Acute rejection rate(6 months)
- Plasma BK viral load clearance rate(1, 3, 6 months)
- Acute rejection rate(6 months)
- Glomerular filtration rate (GFR) change(3, 6 months)
- Chronicity score in kidney allograft(6 months)
- Plasma BK viral load clearance rate(1, 3, 6 months)
- 6-month plasma BK VL(6 months)
- Glomerular filtration rate (GFR) change(3, 6 months)
- Chronicity score in kidney allograft(6 months)
研究者
Suwasin Udomkarnjananun
Principle investigator
King Chulalongkorn Memorial Hospital