Budesonide in Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Acute cellular rejection (ACR)
研究概览
简要总结
Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.
详细描述
This study will be a randomized, open-label non-inferiority trial to assess the efficacy, safety and tolerability of budesonide in combination with low-dose FK and standard-dose MMF as post-OLT ISP in comparison to standard ISP (S-ISP). Subjects will include OLT patients age 18 years and older receiving their first single-organ living- or deceased-donor liver transplant. Subjects must have post-operative recovery of graft function and be able to take oral medications before beginning treatment according to the study protocol.
Subjects will be randomized to receive either (1) investigational oral ISP including budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks and assessed for adequacy of graft function, and complications of therapy, particularly ACR
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
- •Adult patients age 18 years or older who undergo initial single-organ living- or deceased-donor liver-transplant surgery. Research participants are required to have satisfactory post-operative recovery of graft function and no post-operative renal-replacement therapy prior to starting medication according to protocol. They must also be able to take oral medications.
排除标准
- •Patients will be excluded from the study if they are: (1) undergoing retransplantation; (2) have fulminant hepatic failure as an indication for liver transplantation; (3) have surgical complication(s) potentially affecting post-operative graft function (i.e., hepatic artery thrombosis); or have delayed initial recovery of graft function (primary non-function) requiring non-standard induction therapy. Furthermore, patients with a contraindication to budesonide (i.e., hypersensitivity) will not be included in the study
研究组 & 干预措施
Standard immunosuppression arm
Patients treated with standard immunosuppression after liver transplant
干预措施: Prednisone (Drug)
Budesonide treatment arm
Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen
干预措施: Budesonide (Drug)
Budesonide treatment arm
Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen
干预措施: Tacrolimus（FK506） (Drug)
Budesonide treatment arm
Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen
干预措施: Mycophenolate Mofetil (Drug)
Standard immunosuppression arm
Patients treated with standard immunosuppression after liver transplant
干预措施: Tacrolimus（FK506） (Drug)
Standard immunosuppression arm
Patients treated with standard immunosuppression after liver transplant
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Acute cellular rejection (ACR)
时间窗: 12 months
Incidence of ACR in budesonide treatment arm as compared to standard treatment arm
次要结局
- Tacrolimus trough levels(12 months)
- Diabetes(12 months)
- Worsening kidney function(12 months)
- Hyptertension(12 months)
- Graft survival(12 months)
- Patient survival(12 months)
- Infection(12 months)