Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Kidney function
研究概览
简要总结
Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®/Astagraf XL®, Astellas company).
详细描述
This study wants to assess the efficacy of an extended-release formulation of tacrolimus (Advagraf®/Astagraf XL®) used in conjunction with an mTOR-inhibitor agent (sirolimus ) instead of MMF to evaluate the hypothesis that this regimen is associated with good allograft outcome, and might also prevent late-onset cytomegalovirus infection. Advagraf®-based immunosuppression given to de novo kidney-transplant recipients may also increase patients' adherence to treatment due to once-daily usage of the drug.
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 (Participant)
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
- •All Kidney transplant recipients
排除标准
- •Kidney-Pancreas transplant BMI>30 cPRA>0%
研究组 & 干预措施
Intervention
Advograf plus Rapamiune plus Prednisolone
干预措施: Rapamune Pill (Drug)
结局指标
主要结局
Kidney function
时间窗: through study completion, an average of 1 year
gfr measurement
Post-transplant viral Infections
时间窗: through study completion, an average of 1 year
Number of participents with positive blood tests of CMV and BK as assessed by PCR
次要结局
未报告次要终点
研究者
nooshin dalili
assistant professor
Shahid Beheshti University of Medical Sciences