NCT03596970撤回3 期
A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Renal Function
研究概览
简要总结
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)
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
- •Patients willing and capable of providing written informed consent for study participation.
- •Adults 18 to 70 years of age.
- •Liver allograft from a deceased or living donor.
- •Treated with a CNI containing immunosuppressive regimen.
- •Liver transplant 6 to 24 months prior to screening.
- •Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.
- •Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).
排除标准
- •Multiple solid organ transplant recipients
- •Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
- •Malignant diseases other than neoplasms of the skin.
- •Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
- •Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
- •HIV positivity
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Everolimus with MMF (TAC-withdrawal)
Experimental
Everolimus (RAD001) with MMF and Steroids
干预措施: TAC withdrawal (Drug)
Everolimus with reduced TAC
Active Comparator
Everolimus (RAD001) with reduced TAC and Steroids
干预措施: Everolimus with reduced TAC (Drug)
结局指标
主要结局
Renal Function
时间窗: Randomization to Month 6
The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.
次要结局
- Efficacy (tBPAR, graft loss, death, loss to follow-up)(To Month 6)
研究者
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