NCT00402532已完成3 期
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
研究概览
简要总结
The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of Single or Bilateral Lung Transplantation
- •Informed consent
- •Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
- •women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
- •women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
- •donor must not have relevant pulmonary diseases
- •donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.
排除标准
- •systemic infection of the donor
- •donor: signs or symptoms of aspiration
- •donor: severe pulmonary injury or contusion
- •donor: malignant neoplasm of the lung
- •donor: HIV positive
- •recipients who receive immunosuppressive agents not used in this protocol
- •recipients who participated within 30 days before study start or are currently participating in another investigational drug trial
- •HIV positive recipient
- •systemic infection of the recipient
- •recipients of combined/ multiple transplantations
- •pregnancy of the recipient
- •recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses
- •recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation
研究组 & 干预措施
Everolimus
Active Comparator
干预措施: Everolimus (Drug)
Mycophenolatmofetil
Active Comparator
干预措施: Mycophenolatmofetil (Drug)
结局指标
主要结局
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
时间窗: 2 years
次要结局
- Incidence and severity of Nephrotoxicity within 2 years of transplantation(2 years)
- Incidence and severity of opportunistic infections within 2 years of transplantation(2 years)
研究者
Martin Strueber
Martin Strueber, MD
Hannover Medical School
研究点 (1)
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