A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- Mean Creatinine Clearance Rate
研究概览
简要总结
The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation
- •Donor must be at least 60 years old.
排除标准
- •Current systemic infection
- •Unstable angina or treatment for serious arrhythmia.
- •Cancer within the previous 5 years.
研究组 & 干预措施
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
干预措施: sirolimus (Drug)
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
干预措施: mycophenolate mofetil (Drug)
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
干预措施: corticosteroids (Drug)
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
干预措施: daclizumab (Drug)
2
Cyclosporine + Mycophenolate + Corticosteroids
干预措施: cyclosporine (Drug)
2
Cyclosporine + Mycophenolate + Corticosteroids
干预措施: mycophenolate mofetil (Drug)
2
Cyclosporine + Mycophenolate + Corticosteroids
干预措施: corticosteroids (Drug)
结局指标
主要结局
Mean Creatinine Clearance Rate
时间窗: 12 months
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
次要结局
- Number of Patients With Acute Rejection(3 and 12 months)
- Patient and Graft Survival(12 months)
- Mean Creatinine Clearance Rate - 3 Months(3 months)