NCT00098735已完成3 期
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Death within 6 months post transplant
研究概览
简要总结
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.
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
- •First kidney transplantation
- •Male and female patients
- •Between 18 and 65 years old
排除标准
- •Patient in need of multi-organ transplant
- •Patients with history of cardiac arrest
- •Patients with any past or present malignancy
结局指标
主要结局
Death within 6 months post transplant
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
Surgical removal of graft within 6 months post transplant
Permanent resumption of dialysis within 6 months post transplant
Withdrawal of consent, death, or lost to follow up within 6 months post transplant
次要结局
- Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
- FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12
- Permanent resumption of dialysis within 12 months post transplant
- Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
- 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
- Withdrawal of consent, death, or lost to follow up within 12 months post transplant
研究者
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