NCT00099736已完成3 期
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
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
- 696
- 主要终点
- withdrawal of consent, death, or lost to follow up within 12 months post transplant
研究概览
简要总结
The efficacy and safety of FTY720 is being evaluated in patients who receive 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
- Double (Participant, Investigator)
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
- •First kidney transplantation
- •Male and female patients
- •Between 18 and 65 years old
排除标准
- •Patients in need of multiple organ transplants
研究组 & 干预措施
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,
Experimental
干预措施: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids (Drug)
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
Experimental
干预措施: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids (Drug)
MMF 2 g + full-dose Neoral (FDN) + corticosteroids
Experimental
干预措施: MMF 2 g + full-dose Neoral (FDN) + corticosteroids (Drug)
结局指标
主要结局
withdrawal of consent, death, or lost to follow up within 12 months post transplant
surgical removal of graft within 12 months post transplant
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
death within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant
次要结局
- serum creatinine
- absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
- FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
- cystatin C at months 3, 6, and 12
- proteinuria at day 28, months 6 and 12
研究者
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