NCT00098007已完成3 期
Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 39
- 主要终点
- Renal function at 6 months post-transplant.
研究概览
简要总结
The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy.
This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Renal function at 6 months post-transplant.
次要结局
- Incidence of graft loss at 6 months.
- Incidence of death at 6 months.
- Incidence of acute rejection associated with hemodynamic compromise at 6 months.
- Incidence of biopsy proven acute rejection ≥3A at 6 months.
- Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.
研究者
研究点 (39)
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