EUCTR2007-003561-40-DE进行中（未招募）不适用
A Pilot Study to Determine the Safety and Efficacy of Induction-Therapy, De Novo MPA and Delayed mTOR-Inhibition in Liver Transplant Recipients with Impaired Renal Function - PATRON-Study - CNI-free Prevention of Rejection in Liver Transplant Patients with Impaired Renal Function
Regensburg University Medical Center, Department of Surgery0 个研究点目标入组 29 人开始时间: 2008年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients undergoing primary liver transplantation.
- •2.Patients with a hepatorenal syndrome
- •3.eGFR < 50 ml/min at the time point of transplantation
- •4.Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with pre-transplant renal replacement therapy > 14 days.
- •2.Patients with hepatocellular carcinoma.
- •3.Patients with a reason for renal impairment other than a hepatorenal syndrome.
- •4.Patients with a known hypersensitivity to mTOR-inhibitors.
- •5.Patients with a known hypersensitivity to mycophenolate acid.
- •6.Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
- •7.Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.
- •8.Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
- •9.Severe systemic infections and wound-healing disturbances.
- •10.Multiple organ graft recipients.
- •11.Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with Sirolimus.
- •12.Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
- •13.Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
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