EUCTR2008-004158-33-BE进行中（未招募）不适用
CYP3A4/5 and PGP activity in renal transplantation.A study assessing in vivo hepatic and intestinal CYP3A4/5 and PGP activity in kidney transplant recipients and its relationship with genetic and non-genetic variables and the pharmacokinetics and metabolism of Tacrolimus.
Department of Nephrology and Renal Transplantation, KU Leuven0 个研究点开始时间: 2008年9月9日最近更新:
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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
- •- Chronic stable renal allograft recipients (> 1 year after transplantation) treated with Tacrolimus (Prograft® or Advagraf®).
- •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, Midazolam or Fexofenadine.
- •- 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.
研究者
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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.Effect of genetic (single nucleotide polymorphisms of genes encoding drug metabolising enzymes and drug transporters) and non-genetic factors (e.g. age, time after transplantation, concommitant medication, renal function, liver dysfunction) on in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients.MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplantEUCTR2007-004069-16-BEDepartment of Nephrology and Renal Transplantation, KU Leuven
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