A Two-year Extension to a One-year, Multicenter, Open-label, Randomised Study to Evaluate the Safety and Efficacy of FTY720 Combined With Tacrolimus and Steroids Versus Mycophenolate Mofetyl Combined With Tacrolimus and Steroids, in de Novo Adult Renal Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- IA, IB, IIA, IIB, III, or humoral rejection 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 tacrolimus 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
- •Completed the 12 month core study
- •Informed consent
排除标准
- •N/A Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
IA, IB, IIA, IIB, III, or humoral rejection 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
Withdrawal of consent, death, or lost to follow up within 36 months post transplant
Serum creatinine, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36
Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
Absolute lymphocyte count at Month 18, 24, 30 and 36.
次要结局
- Physical examinations at Months 18, 24, 30 and 36
- Vital signs at Months 18, 24, 30 and 36
- Electrocardiogram at Months 24 and 36
- Chest X-ray Months 24 and 36
- Safety laboratory tests 18, 24, 30 and 36
- Ophthalmic evaluations 18, 24, 30 and 36
- AEs and SAEs
- FTY720/CsA levels at Months 18, 24, 30 and 36