NL-OMON54135招募中不适用
Personalized Use of Resources study - PURE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a. Patients aged 18 to 70 years, with a stable renal function
- •b. Patients who are at least 6 months until five years after first
- •transplantation, who are not immunized (PRA<5%) with therapeutic tacrolimus
- •concentrations between 4-9 ng/L and on a stable tacrolimus dose (are using the
- •same dosage of Tacrolimus extended release for the last month) with
- •Tacrolimus-Extended-Release with a C/D ratio < 1.05 ng/mL×1/mg
- •c. Patients must provide written informed consent
- •d. Patients of childbearing potential must agree to use highly effective
- •methods of contraception during the study.
排除标准
- •a. Patient received or is receiving treatment for acute rejection prior to
- •initiation of study
- •b. Donor Specific antibody positivity and patients who are immunized (PRA>=5%)
- •c. Chronic diarrhoea
- •d. Use of phenytoin, carbamazepine, phenobarbital, primidone, rifampin,
- •caspofungin, erythromycin, clarithromycin, fluconazole, ketoconazole,
- •itraconazole, posaconazole, voriconazole, fluoxetine, fluvozamine, sertraline,
- •venlafaxine, mirtazapine, paroxetine, diltiazem, verapramil, amiodaron
- •e Thyroid dysfunction
- •f. Excessive use of caffeine (more than use of 5 IE daily)
- •g. Excessive use of alcohol (more than 2 IE daily)
- •h.. Patients who are pregnant.
研究者
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