Steroid Free Immunosuppression in Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Graft Survival Rate
研究概览
简要总结
The purpose of this study is to determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.
详细描述
Steroids have remained a standard part of post-transplant immunosuppression, both for prevention and treatment of rejection. However, steroids have been shown to cause long-term adverse effects, such as: susceptibility to infection, obesity, hypertension, hyperlipidemia, diabetes, osteopenia, cataracts and growth retardation in children. They have also been implicated in accelerating Hepatitis C virus (HCV) re-infection post-liver transplantation.
Several studies have shown that early steroid reduction or withdrawal could be done safely to alleviate many steroid-related adverse effects after liver transplantation (OLT).
This is a prospective controlled randomized trial on adult patients who will undergo primary OLT at Thomas Jefferson University Hospital (TJUH).
Forty consecutive OLT recipients shall be randomized into two groups.
- Control group- immuno-suppressive drug regimen consisting of basiliximab (Simulect), tacrolimus (Prograf), Mycophenolic acid (Myfortic), and steroids
- Study group- immuno-suppressive drug regimen consisting of basiliximab, tacrolimus, Mycophenolic acid (Myfortic) without steroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 72 years of age
- •Male or female patients who are primary cadaveric liver transplant recipients
- •Cold ischemia time must be <20 hours
- •Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
- •Patient has given written informed consent to participate in the study
排除标准
- •Patients meeting any of the following criteria at baseline will be excluded from study participation
- •Patients who have previously received an organ transplant
- •Patients who are recipients of a multiple organ transplants
- •Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding
- •Known sensitivity to Simulect or class of Simulect
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Use of any other investigational agent in the last 30 days
研究组 & 干预措施
Steroid -free immunosuppression
Study group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA)
干预措施: Basiliximab (Drug)
Steroid -free immunosuppression
Study group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA)
干预措施: Tacrolimus (Drug)
Steroid -free immunosuppression
Study group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA)
干预措施: Enteric-coated Mycophenolic acid (EC-MPA) (Drug)
Steroid containing immunosuppression
Control group- Basiliximab, Tacrolimus, EC-MPA, steroids
干预措施: Steroids (Drug)
Steroid containing immunosuppression
Control group- Basiliximab, Tacrolimus, EC-MPA, steroids
干预措施: Basiliximab (Drug)
Steroid containing immunosuppression
Control group- Basiliximab, Tacrolimus, EC-MPA, steroids
干预措施: Tacrolimus (Drug)
Steroid containing immunosuppression
Control group- Basiliximab, Tacrolimus, EC-MPA, steroids
干预措施: Enteric-coated Mycophenolic acid (EC-MPA) (Drug)
结局指标
主要结局
Graft Survival Rate
时间窗: 1 and 2 years
Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.
Patient Survival Rate
时间窗: 1 and 2 years
Percentage of recipients who are still alive at the end of 1 and 2 years.
Acute Rejection Rate
时间窗: 6 months post-transplant
Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive
次要结局
- Infection as an Adverse Effect of Steroids(3 months post-transplant)
- Incidence and Severity of HCV Recurrence Post-OLT(6 months post-transplant)
- New-onset Diabetes Mellitus (NODM) as Secondary Outcome(6 months)