A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 684
- 主要终点
- Withdrawal of consent, death, or lost to follow up within 36 months post transplant
研究概览
简要总结
This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) 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
Withdrawal of consent, death, or lost to follow up within 36 months post transplant
Serum creatinine, calculated creatinine clearance and urine-protein/creatinine rati at Months 18, 24, 30 and 36 o
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Death within 36 months post transplant
Permanent resumption of dialysis within 36 months post transplant
Surgical removal of graft within 36 months post transplant
Absolute lymphocyte count at Month 18, 24, 30 and 36.
次要结局
- Electrocardiogram at Months 24 and 36
- Physical examinations at Months 18, 24, 30 and 36
- Vital signs at Months 18, 24, 30 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