NCT00097968已完成3 期
An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 11
- 主要终点
- Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
研究概览
简要总结
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation.
It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.
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
- Prevention
- 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
- •Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.
- •Patient must be on statins at study entry.
- •Patient who is more than 12 months post-transplant.
排除标准
- •Patient with a serum creatinine value >2.0 mg/dL.
- •Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months prior to study entry.
- •Patient who had received any investigational drug within 4 weeks prior to study entry.
结局指标
主要结局
Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
次要结局
- Treated acute rejection at 3 and 6 months.
- Admission to the hospital at 3 and 6 months.
- Major Adverse Cardiac Events at 3 and 6 months.
- Patient survival at 3 and 6 months.
- Premature study treatment discontinuation at 3 and 6 months.
研究者
研究点 (11)
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