NCT00048152已完成3 期
A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
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
- 539
- 主要终点
- Renal function (as measured by GFR)
研究概览
简要总结
This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
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
- •adult patients greater than 18 years of age
- •recipients of primary kidney transplant
- •single-organ recipients (kidney only)
排除标准
- •previous treatment with Zenapax
- •history of malignancy (except localized skin cancer)
研究组 & 干预措施
1
Experimental
干预措施: Corticosteroids (Drug)
1
Experimental
干预措施: Neoral (Drug)
1
Experimental
干预措施: Zenapax (Drug)
1
Experimental
干预措施: mycophenolate mofetil [CellCept] (Drug)
2
Experimental
干预措施: Corticosteroids (Drug)
2
Experimental
干预措施: Neoral (Drug)
2
Experimental
干预措施: Zenapax (Drug)
2
Experimental
干预措施: mycophenolate mofetil [CellCept] (Drug)
3
Experimental
干预措施: Corticosteroids (Drug)
3
Experimental
干预措施: Neoral (Drug)
3
Experimental
干预措施: mycophenolate mofetil [CellCept] (Drug)
结局指标
主要结局
Renal function (as measured by GFR)
时间窗: 12 months post-transplant
次要结局
- AEs, OIs, malignancies, deaths(Throughout study)
- Patient and graft survival \n(12 months post-transplant)
- Proportion of patients with biopsy-proven rejection; treatment failure.(6 and 12 months post-transplant)
研究者
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