Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- longterm glomerular filtration rate defined by eGFR CKD-EPI
研究概览
简要总结
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
详细描述
Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.
The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year
排除标准
- •history of acute rejection, or subclinical rejection
结局指标
主要结局
longterm glomerular filtration rate defined by eGFR CKD-EPI
时间窗: 5 years
次要结局
- Acute rejection rate(5 years)
研究者
Natavudh Townamchai, MD
MD
Chulalongkorn University