A 6-month, Multicenter, Randomized, Open-label Study of Safety and Efficacy of Everolimus-based Regimen Versus Calcineurin Inhibitor (CNI)-Based Regimen in Maintenance Liver Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)
研究概览
简要总结
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.
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 70 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
研究组 & 干预措施
Reduced CNI dose + everolimus ± steroids
Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids
干预措施: Everolimus (Drug)
Reduced CNI dose + everolimus ± steroids
Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids
干预措施: Calcineurin inhibitors (CNI) (Drug)
Reduced CNI dose + everolimus ± steroids
Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids
干预措施: Steroids (Drug)
CNI continuation ± MPA/AZA ± Steroids
Standard CNI dose ± MPA/AZA ± steroids
干预措施: Calcineurin inhibitors (CNI) (Drug)
CNI continuation ± MPA/AZA ± Steroids
Standard CNI dose ± MPA/AZA ± steroids
干预措施: Mycophenolate acid (MPA)/ Azathioprine (AZA) (Drug)
CNI continuation ± MPA/AZA ± Steroids
Standard CNI dose ± MPA/AZA ± steroids
干预措施: Steroids (Drug)
结局指标
主要结局
Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)
时间窗: From baseline to 6 months
The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits. CrCl\[mL/min\] = (140 - A) \* W / (72 \* C) \* R. Where A is age at sample date \[years\], W is body weight at specific visit \[kg\], C is the serum concentration of creatinine \[mg/dL\], R = 1 if the patient is male and = 0.85 if female.
次要结局
- Number of Patients With Discontinuation of Study Medication(6 months)
- Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)(6 months)