NCT00297765已完成4 期
OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 42
- 主要终点
- The effect of conversion from cyclosporine to Prograf-based therapy on renal function
研究概览
简要总结
A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.
详细描述
A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was 18 years of age at the time of transplant.
- •Patient is at least 6 months post-transplant.
排除标准
- •Patient is the recipient of a solid organ transplant other than the kidney.
- •Patient is a known carrier of any of the HIV viruses.
结局指标
主要结局
The effect of conversion from cyclosporine to Prograf-based therapy on renal function
时间窗: 12 months
次要结局
- Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival(24 months)
研究者
研究点 (42)
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