A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
研究概览
简要总结
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
详细描述
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients undergoing deceased donor solitary liver transplantation
- •Adults aged 18-70 at time of transplantation
- •Hepatocellular carcinoma as indication for OLT within the Milan Criteria
- •Hepatitis C positive or negative patients
- •Willingness to comply with study procedures
- •Able to sign informed consent
排除标准
- •Prior kidney transplantation
- •Congenital or iatrogenic absence of one kidney
- •Subjects on renal replacement therapy at the time of OLT
- •MELD score > 28
- •HIV positive patient
- •Patient with current severe systemic infection
- •History of bacterial peritonitis within 30 days prior to OLT
- •Active infection or recent infection within 30 days prior to OLT
- •Use of calcineurin inhibitor continuously for more than 90 days within the past 6 months
- •History of hypersensitivity to thymoglobulin, rabbits, tacrolimus or iohexol
- •Women of childbearing age who are unwilling to use effective contraceptive methods during the duration of the study
研究组 & 干预措施
Delayed CNI Group 1
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
干预措施: Thymoglobulin 3mg total (Biological)
Delayed CNI Group 2
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
干预措施: tacrolimus 3-8 (Drug)
Delayed CNI Group 1
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
干预措施: Mycophenolate mofetil (Drug)
Delayed CNI Group 1
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
干预措施: tacrolimus 3-8 (Drug)
Delayed CNI Group 2
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
干预措施: Thymoglobulin 4.5mg total (Biological)
Delayed CNI Group 2
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
干预措施: Mycophenolate mofetil (Drug)
Early CNI / Control Arm
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
干预措施: Mycophenolate mofetil (Drug)
Early CNI / Control Arm
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
干预措施: tacrolimus 8-12 (Drug)
结局指标
主要结局
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
时间窗: 12 Months
Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
次要结局
- Allograft Rejection Rates at 30 Days(30 days)
- Patient Survival(12 months post-transplant)
- Graft Survival(12 months post transplant)
研究者
Bijan Eghtesad, MD
HPBT Staff Surgeon
The Cleveland Clinic