A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 607
- 主要终点
- Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
研究概览
简要总结
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 13 years (age greater than 18 years as required by some local regulations).
- •Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
- •6 to 144 months after orthotopic liver transplantation.
- •Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening
排除标准
- •History of nonhepatic transplantation
- •Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- •Known or suspected malignancy < 5 years before random assignment.
研究组 & 干预措施
A
干预措施: Sirolimus (Rapamune) (Drug)
B
干预措施: Cyclosporine or Tacrolimus (Drug)
结局指标
主要结局
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
时间窗: Baseline and 12 months
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is \>90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Patient and Graft Survival
时间窗: 12 months
Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.
次要结局
- Number of Patients With a Biopsy Confirmed Acute Rejection(12 months)
- Mean Serum Creatinine(12 months)