Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Renal Function Assessed by Measured GFR (mGFR)
研究概览
简要总结
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient at least 18 years of age.
- •Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
- •Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
- •The immunosuppressive regimen must remain unchanged within the last 3 months.
- •Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m^2 by Cockcroft-Gault formula.
排除标准
- •Patient who is recipient of multiple organ transplants.
- •Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
- •Patient with a treated acute rejection episode within the last 3 months.
- •Patient with any past or present BK-polyomavirus nephropathy.
- •Patient with de novo or recurrent glomerular nephritis.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group C: CNI Reduction
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
干预措施: Calcineurin Inhibitors (CNI) (Drug)
Group A: No RAD
Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
干预措施: Calcineurin Inhibitors (CNI) (Drug)
Group A: No RAD
Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
干预措施: Mycophenolate acid (MPA)/Azathioprine (AZA) (Drug)
Group A: No RAD
Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
干预措施: Steroids (Drug)
Group B : CNI Withdrawal
Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.
干预措施: Everolimus (RAD001) (Drug)
Group B : CNI Withdrawal
Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.
干预措施: Mycophenolate acid (MPA)/Azathioprine (AZA) (Drug)
Group B : CNI Withdrawal
Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.
干预措施: Steroids (Drug)
Group C: CNI Reduction
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
干预措施: Everolimus (RAD001) (Drug)
Group C: CNI Reduction
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
干预措施: Mycophenolate acid (MPA)/Azathioprine (AZA) (Drug)
Group C: CNI Reduction
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
干预措施: Steroids (Drug)
结局指标
主要结局
Renal Function Assessed by Measured GFR (mGFR)
时间窗: 24 months
The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.
次要结局
- Number of Participants With Safety Parameters(24 months)