A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Estimated Glomerular Filtration Rate (GFR)
研究概览
简要总结
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
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 65 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
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
干预措施: Everolimus (Drug)
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
干预措施: Tacrolimus (Drug)
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: < 5 ng/mL)
干预措施: Corticosteroids (Drug)
TAC
Tacrolimus (C0-h: 6-10 ng/ml)
干预措施: Tacrolimus (Drug)
TAC
Tacrolimus (C0-h: 6-10 ng/ml)
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Estimated Glomerular Filtration Rate (GFR)
时间窗: month 12
The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).
次要结局
- Estimated GFR - PP Set(month 12)
- Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death(12 months)
- Number of Participants With HCV(12 months)
- Incidence of HCV Related Fibrosis(12 months)
- Incidence and Severity of CMV Viral Infections.(12 months)
- Incidence of de Novo HCC Malignancies(12 months)