NCT00239902已完成2 期
Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 主要终点
- IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
研究概览
简要总结
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
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
IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Permanent resumption of dialysis within 36 months post transplant
Surgical removal of graft within 36 months post transplant
Death within 36 months post transplant
Discontinuation within 36 months post transplant
次要结局
- FEV1 , FVC, DLCO within 36 months post transplant
- Serum creatinine and estimated creatinine clearance within 36 months post transplant
- Absolute lymphocyte count within 36 months post transplant
研究者
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