EUCTR2007-004069-16-BE进行中（未招募）不适用
Hepatic and intestinal CYP3A4/5 activity in renal transplantation.A study assessing in vivo hepatic and intestinal CYP3A4/5 activity at different time-points and in different clinical settings after renal transplantation and its relationship with genotype, pharmacokinetics and metabolism of Tacrolimus and outcome.
Department of Nephrology and Renal Transplantation, KU Leuven0 个研究点开始时间: 2007年10月3日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 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
- •- De novo primary renal allograft recipients.
- •- Chronic stable renal allograft recipients.
- •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
- •- Age < 18 years.
- •- Females with child bearing potential, not using an acceptable method of birth control.
- •- Nursing and pregnant women. Pregnancy tests will be performed before drug administration.
- •- Known allergy or intolerance to either Erythromycin or Midazolam.
- •- Concomitant treatment with opioid- or antipsychotic drugs.
- •- Severe chronic lung disease and chronic respiratory insufficiency.
- •- Chronic heart failure.
- •- Severe liver disease.
- •- Anaemia (haemoglobin < 11 g/dL).
- •- Hypoalbuminemia (< 25 g/L).
- •- Combined organ transplants.
- •- Known non-compliance.
- •- Alcohol intake > 7 units/week.
- •- Smoking.
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