A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus
研究概览
简要总结
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
详细描述
This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study.
Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（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
Everolimus + reduced tacrolimus
Everolimus + reduced tacrolimus ± corticosteroids
干预措施: Everolimus + reduced tacrolimus (Drug)
Standard tacrolimus
Standard tacrolimus ± corticosteroids
干预措施: Standard tacrolimus (Drug)
结局指标
主要结局
Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus
时间窗: 12 months post transplantation
Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR ≥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months
次要结局
- Compare Incidence of Notable Safety Events (SAEs, Infections and Serious Infections Leading to Premature Discontinuation)(Month 24)
- Composite Efficacy Failure of Treated Biopsy in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus in Patients From Japan Only(randomization, 36 months post transplantion)
- Renal Function by Estimated Glomerular Filtration Rate (All Extension Patients)(randomization, at 36 months post transplantation)
- Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization(From randomization to month 12)
- Compare Renal Function Over Time Assessed by the Change by eGFR, Post-randomization(From randomziation to month 24)
- Compare Incidence of tBPAR(Month 12 and Month 24 post transplantation)
- Number of Subjects Experiencing Adverse Events/Infections by SOC(Month 24)
- Number of Participants With Composite of tBPAR, Graft Loss, and Death(Month 24 post transplantation)
- Compare Incidence of BPAR(Month 12 and Month 24 post transplantation)
- Compare Incidence of Graft Loss(Month 12 and Month 24 post transplantation)
- Compare Incidence of tAR(Month 12 and Month 24 post transplantation)
- Compare Incidence of a Composite of Death or Graft Loss(Month 12 and Month 24 post transplantation)
- Compare Incidence of Death(Month 12 and Month 24 post transplantation)
- Compare Incidence of AR(Month 12 and Month 24 post transplantation)
- Number of Participants With Time to Recurrence of HCC in Subjects With a Diagnosis of HCC at the Time of Liver Transplantation(Month 12 and Month 24)