A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol
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
- Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
研究概览
简要总结
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
详细描述
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 90 days post transplant.
- •Free from rejection within the last 30 days.
- •Patient with primary diagnosis of AIH will be evaluated on an individual basis.
- •Negative pregnancy test.
- •Practicing an acceptable method of birth control.
- •Capable of providing written informed consent.
排除标准
- •Rejection within the last 30 days.
- •Patients with AIH unable to discontinue corticosteroids.
- •Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
- •Known sensitivity or contraindication to tacrolimus or MMF.
- •Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
- •Pregnant or lactating.
研究组 & 干预措施
Immunosuppression
All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
干预措施: tacrolimus (Drug)
Immunosuppression
All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
干预措施: mycophenolate mofetil (Drug)
Immunosuppression
All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
干预措施: Prednisone (Drug)
结局指标
主要结局
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
时间窗: 12 months
次要结局
- Patient Survival.(12 months)
研究者
E. Steve Woodle
MD, FACS
University of Cincinnati