EUCTR2009-017843-32-NL进行中（未招募）1 期
A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function and development of de novo malignancy in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus. - LOL-III
Foundation of Liver Research (SLO)0 个研究点开始时间: 2010年7月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Primary liver transplantation or retransplantation within 14 days after first transplantation
- •Use of Advagraf at least 2 weeks prior to randomization
- •Patent hepatic artery
- •Closed abdominal wound
- •Stable graft function
- •Positive informed consent at time of randomization
- •Age 18-70 years
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Treatment with investigational drugs within 3 months before start of therapy
- •Multi organ transplantation
- •cGFR < 30 ml/min
- •Proteinuria > 800 mg/24 h
- •Hypersensitivity to sirolimus
- •Thrombocytes < 50 x 109 /L
- •Leukocytes < 2.5 x 109 /L
- •Haemoglobin < 6 mmol/L
- •Biopsy proven rejection 2 weeks prior to randomization
- •HIV positivity
- •Signs of recurrent or de novo cancer
- •Pregnancy or breast feeding
- •Systemic infection
- •Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
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