Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- death or graft loss
研究概览
简要总结
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
详细描述
The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.
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
- •preceding renal transplantation
- •functioning graft with a permanent creatinine clearance of more than 25mL/min
- •biopsy-confirmed polyoma BK virus nephropathy
- •age over 18 years old
排除标准
- •allergy or non-tolerance of the study medication everolimus
- •pregnancy
研究组 & 干预措施
mTOR-receiving arm
switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
干预措施: mTOR inhibitor (everolimus) (Drug)
calcineurin-inhibitor keeping arm
continuing calcineurin-inhibitor based immunosuppression
干预措施: cyclosporine or tacrolimus (Drug)
结局指标
主要结局
death or graft loss
时间窗: 2 years of observation
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function
次要结局
- decrease of polyomavirus serum PCR(2 years)
- decrease of creatinine(2 years observation)
- progression of chronic changes in renal histology(renal biopsy 3 months after intervention)
- number of rejections following intervention(2 years after intervention)
- increase of BKV-specific T-cells(2 years observation)