NCT00154193已完成4 期
A 12-month Study to Investigate the Correlations Between Cyclosporine Microemulsion C2 Levels (High, Medium and Low) and AUC0-4 With Regard to Outcome in de Novo Heart and Lung Transplantation - Identification of Target Cyclosporine Microemulsion C2 Levels.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant
研究概览
简要总结
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients receiving a first heart or bilateral or single lung transplant
- •Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.
排除标准
- •Multi-organ transplants or previously transplanted organs
- •Patients with the need of more than two cyclosporine microemulsion dosages per day
- •Other protocol-defined inclusion/exclusion criteria may applied
研究组 & 干预措施
Cyclosporine
Active Comparator
干预措施: cyclosporine (Drug)
结局指标
主要结局
The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant
The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant
次要结局
- Incidence of treated acute rejections
- Patient and Graft survival rates
- Incidence of biopsy-proven acute cellular rejections
研究者
研究点 (1)
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