A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Steroid resistant rejection
研究概览
简要总结
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary liver transplantation.
- •Patients older than 18 years.
- •Patients with a hepatorenal syndrome.
- •Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
- •eGFR < 50 ml/min at the time point of transplantation.
- •Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.
排除标准
- •Patients with pre-transplant renal replacement therapy > 14 days.
- •Patients with a reason for renal impairment other than a hepatorenal syndrome.
- •Patients with a known hypersensitivity to mTOR-inhibitors.
- •Patients with a known hypersensitivity to mycophenolate acid.
- •Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
- •Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.
- •Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
- •Severe systemic infections and wound-healing disturbances.
- •Multiple organ graft recipients.
- •Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
- •Pregnant women will not be included in the study.
- •Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).
研究组 & 干预措施
CNI-free Immunosuppression
Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.
干预措施: Basiliximab (Simulect) (Drug)
CNI-free Immunosuppression
Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.
干预措施: Myfortic (Drug)
CNI-free Immunosuppression
Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.
干预措施: everolimus (Drug)
CNI-free Immunosuppression
Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Steroid resistant rejection
时间窗: 30 days
次要结局
- Steroid resistant rejection(1 year)
- Liver function(1 year)
- Calculated glomerular filtration rate(1 year)
- Patient survival(1 year)
- Number of days on renal replacement therapy(1 year)
- Graft survival(1 year)
研究者
Armin Goralczyk
Dr.
University Medical Center Goettingen