A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18
研究概览
简要总结
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
详细描述
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
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 70 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
CNI-regimen
CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
干预措施: Everolimus (EVR) (Drug)
CNI-regimen
CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
干预措施: cyclosporine A (CyA) (Drug)
CNI-regimen
CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
干预措施: tacrolimus (TAC) (Drug)
CNI-regimen
CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
干预措施: Corticosteroids (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: Everolimus (EVR) (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: cyclosporine A (CyA) (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: tacrolimus (TAC) (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: Enteric coated mycophenolate sodium (EC-MPS) (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: mycophenolate mofetil (MMF) (Drug)
CNI-free-regimen
CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18
时间窗: Month 18
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.
次要结局
- Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18(Month 6 to Month 9; Month 9 to Month 18)
- Occurrence of Major Cardiac Events (MACE) From Month 6 to 18(Month 6 to Month 18)
- Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18(Month 12 and 18)
- Serum Creatinine at Month 6, 8, 9, 10 12 and 18(Month 6, 8, 9, 10 12 and 18)
- Reciprocal Creatinine Slope Between Month 6 and Month 18(Between Month 6 and Month 18)