Evaluation of the Effects of Sirolimus Addition to the Triple Immunosuppression Protocol on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Sensitized Kidney Transplant Recipients - a Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- A composite of graft loss and/or death with graft function
研究概览
简要总结
The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18 to 60 years inclusive
- •Percentage of Panel Reactive Antibodies at transplantation > 20%
- •Estimated glomerular filtration rate using MDRD formula at inclusion >29ml/min
排除标准
- •Subjects with a history of cancer
- •Subjects with a previous non kidney transplantation
- •Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
- •Subjects with a urinary protein/creatinine ratio greater than 0.3
- •Subjects with active HBV, HCV and HIV infection
研究组 & 干预措施
Tacrolimus/MPS/Prednisone
This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm
干预措施: No intervention (Drug)
Sirolimus/Low Tacrolimus/MPS/Prednisone
Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..
干预措施: Sirolimus (Drug)
结局指标
主要结局
A composite of graft loss and/or death with graft function
时间窗: up to one year
次要结局
- Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection(Up to one year)