A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant
研究概览
简要总结
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 years or older
- •Recipients of a first-time liver transplant
- •Serum Creatinine level less than 2.0 on Post-Operative Day 3-7
- •Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
排除标准
- •Any prior use of tacrolimus or cyclosporine
- •Recipients of prior organ transplant
- •Need for hemodialysis in the week preceding or following liver transplantation
- •Recipients of living donor liver or split deceased donor liver allografts
- •Recipients of combined liver/kidney transplants
- •Pregnancy or lactation
- •Recipients of ABO incompatible liver allografts
研究组 & 干预措施
Envarsus XR
Envarsus XR orally administered Daily
干预措施: Envarsus XR (Drug)
Prograf
Prograf PO administered twice daily Generic Name: tacrolimus
Dosage of prograf will be determined by trough levels and adjusted accordingly
干预措施: Prograf (Drug)
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant
时间窗: 3, 6, and 12 months post-transplant
We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation.
次要结局
- Quality of Life Assessment(3, 6, and 12 months post-transplant)