A Phase 3 Study Comparing the Use of Daclizumab vs Thymoglobulin as Induction Therapy in Lung Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- All cause mortality at 2 years.
研究概览
简要总结
The purpose of this study is to compare outcomes in patients undergoing lung transplantation, using 2 different induction therapies. Primary outcome is survival and secondary outcomes include freedom from infection and freedom from rejection.
详细描述
Acute and chronic allograft rejection are two of the common problems limiting and complicating the utility of lung transplantation. The timing and frequency of acute rejection has been shown to be a significant risk factor for the development of chronic allograft rejection. As an adjunct to standard triple immunosuppressive therapy, induction therapy is thought to decrease the incidence of acute rejection.Daclizumab is an interleukin 2 receptor (IL-2) antagonist which is FDA approved as an immunosuppressive agent. Thymoglobulin is an anti-lymphocyte immunosuppressive agent that has been shown in other solid organ transplant studies to be successful in delaying the first episode of rejection but has not decreased the incidence of Obliterative Bronchiloitis (chronic rejection)in lung transplantation.
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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients accepted and listed for lung transplantation will be considered for randomization
排除标准
- •Patients who demonstrate hemodynamic instability, requiring inotropes for greater than 48 hours prior to transplant
- •Severe reperfusion pulmonary edema or primary graft dysfunction requiring FiO2 of > 50% and PEEP > 10 cm for greater than 48 hours prior to transplant
- •Preoperative renal insufficiency (CrCl < 50 gm.d or serum creatinine > 2.0)
- •Pre-operative panel reactive antibodies PRA
- •Preoperative recipient bacterial or fungal colonization
- •Preoperative antimicrobial suppressive therapy
结局指标
主要结局
All cause mortality at 2 years.
次要结局
- 1)Freedom from 1st >/= A2 rejection episode and incidence of rejection over the first 2 years post-transplant
- 2)Freedom from infection