A Randomized, Open-label Study of the Effect of a Long-term Calcineurin Inhibitor-free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 293
- 主要终点
- Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant
研究概览
简要总结
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-74 years of age
- •Single primary liver transplant from a deceased donor
- •CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
- •Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.
排除标准
- •Liver allograft from a living donor or a split liver
- •Multiple organ transplant
- •Dialysis therapy for >14 days from transplantation to randomization
- •History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
- •Previous sirolimus therapy
研究组 & 干预措施
CellCept + CNI (tacrolimus or cyclosporine)
干预措施: mycophenolate mofetil [CellCept] (Drug)
CellCept + CNI (tacrolimus or cyclosporine)
干预措施: Tacrolimus (Drug)
CellCept + CNI (tacrolimus or cyclosporine)
干预措施: Cyclosporine (Drug)
CellCept + sirolimus
干预措施: mycophenolate mofetil [CellCept] (Drug)
CellCept + sirolimus
干预措施: Sirolimus (Drug)
结局指标
主要结局
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant
时间窗: 12 months posttransplant
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
次要结局
- Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant(24 months posttransplant)
- Change From Baseline in Creatinine Clearance(6, 12, and 24 months posttransplantation)
- Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant(6 months posttransplant)