Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- number of episodes of acute rejection after LTx
研究概览
简要总结
The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient placed on the national waiting list for lung transplantation
- •First de novo lung transplantation (single or double LTx)
- •Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)
排除标准
- •Previous lung transplantation or other solid organ transplantation
- •Combined lung transplantation with either liver or renal transplantation
研究组 & 干预措施
new strategy of immunosuppression monitoring
evaluation of calcineurin activity (CN-a) in combination with CNI blood levels
干预措施: levels of CNI in whole blood (Biological)
new strategy of immunosuppression monitoring
evaluation of calcineurin activity (CN-a) in combination with CNI blood levels
干预措施: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) (Biological)
strategy of reference
CNI (inhibitor of Calcineurin) blood levels alone
干预措施: levels of CNI in whole blood (Biological)
结局指标
主要结局
number of episodes of acute rejection after LTx
时间窗: 6 months
次要结局
未报告次要终点