NCT00556257撤回2 期
A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Clinical biopsy proven acute rejection rate at 6 months
研究概览
简要总结
A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of first time kidney transplant
- •Between the ages of 18 and 70 years, inclusive
排除标准
- •Recipient of any non-kidney transplant
研究组 & 干预措施
Treatment Arm 1
Active Comparator
Treatment Arm 1 will also receive standard of care medications.
干预措施: Cyclosporine (Drug)
Treatment Arm 2
Experimental
Treatment Arm 2 will also receive select standard of care medications.
干预措施: CP-690-,550 (Drug)
结局指标
主要结局
Clinical biopsy proven acute rejection rate at 6 months
时间窗: 6 months
次要结局
- Pharmacokinetics of CP-690,550(12 months)
- Lymphocyte subsets(12 months)
- Posttransplant humoral alloreactivity(12 months)
- Safety and tolerability of CP-690,550(12 months)
研究者
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终止
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