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
概览
- 阶段
- 3 期
- 干预措施
- Sirolimus (Rapamune)
- 疾病 / 适应症
- Liver Transplantation
- 发起方
- Wyeth is now a wholly owned subsidiary of Pfizer
- 入组人数
- 607
- 主要终点
- Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
- 状态
- 终止
- 最后更新
- 16年前
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.
研究者
入排标准
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)
B
干预措施: Cyclosporine or Tacrolimus
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)