6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method
研究概览
简要总结
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.
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
- 65 Years 至 —（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
Control group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
干预措施: Basiliximab (Drug)
Control group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
干预措施: Enteric Coated Mycophenolic Acid (MPA) (Drug)
Control group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
干预措施: Cyclosporin A (CsA) (Drug)
Control group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
干预措施: Corticosteroids (Drug)
Everolimus group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
干预措施: Basiliximab (Drug)
Everolimus group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
干预措施: Enteric Coated Mycophenolic Acid (MPA) (Drug)
Everolimus group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
干预措施: RAD001 (Drug)
Everolimus group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
干预措施: Cyclosporin A (CsA) (Drug)
Everolimus group
During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method
时间窗: Month 6
The study was terminated prematurely and not powered for efficacy.
次要结局
- Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method(Month 6)
- Renal Function by Serum Creatinine(Months 6, 12, 24, 36, 48 and 60)
- Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death(Months 6, 12, 24, 36, 48 and 60)
- Occurrence of Treatment Failures(Month 6)
- Evolution of Renal Function (Creatinine Slope)(Week 7, Month 6)
- CD25 Saturation on Lymphocytes(Month 6)
- Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death(Months 6, 12, 24, 36, 48 and 60)
- Renal Function by GFR Over Time(Months 12, 24, 36, 48 and 60)
- Renal Function by Proteinuria(Months12, 24, 36, 48 and 60)