NCT00296361已完成3 期
A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.
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
- 634
- 主要终点
- Renal function as assessed by calculated creatinine clearance at month 6.
研究概览
简要总结
Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.
详细描述
This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 60 years of age and having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.
排除标准
- •Patient has a high immunological risk
- •Cold ischemia time greater than 30 hours
- •Patient has significant liver disease
- •Patient has severe hypercholesterolaemia
- •Patient is allergic or intolerant to study medication
- •Patient requires ongoing dosing with corticosteroids.
- •Patient or donor is known to be HIV positive
- •Patient with malignancy or history of malignancy
研究组 & 干预措施
1
Active Comparator
干预措施: Tacrolimus (Drug)
2
Experimental
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Renal function as assessed by calculated creatinine clearance at month 6.
时间窗: 6 months
次要结局
- Acute rejection: Incidence of and time to first acute rejection(6 months)
研究者
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