EUCTR2009-013461-25-GB进行中（未招募）1 期
The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of twice daily Tacrolimus and Advagraf - Pharmacogenetics of twice daily Tacrolimus and Advagraf
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
入选标准
- •1) Renal transplant recipient at least 6 weeks after transplantation on treatment with twice daily Prograf (Tacrolimus) with planned change in treatment to once daily Advagraf (prolonged release tacrolimus) as part of standard care.
- •2) Aged at least 18 years
- •3) Treatment with 5 mg prednisolone daily
- •4) Signed and dated informed consent obtained before screening and before performance of any protocol-specific tests.
- •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 on treatment with potent cytochrome P4503A and P-glycoprotein inducers or inhibitors:
- •Inducers: Carbamazepine, Phenytoin, Rifampicin
- •Inhibitors: Diltiazem, Erythromycin, Fluconazole, Verapamil
研究者
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