NCT01068067Unknown不适用
Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study
Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- C0 of tacrolimus after the initial dose, the percentage of out-of-range C0 after initial dose, the number of dose adjustments made to achieve therapeutic range (5-10 ng/ml) and the dose requirement to reach therapeutic range
研究概览
简要总结
The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University
- •Wish to participate in the study
- •Informed consent for the trial
排除标准
- •Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus
- •Patients with ABO-incompatible renal transplantation
- •Panel reactive antibody (PRA) levels greater than 30% before transplantation
- •Underwent combined organ transplantations
- •Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used
- •Allergic history to study medicines
- •During pregnancy or plan to get pregnant during the study period
研究组 & 干预措施
pharmacogenetics plus SchE guided dosing
Experimental
干预措施: drug (tacrolimus and SchE) and genetics (Other)
standard dosing
Active Comparator
干预措施: tacrolimus (Drug)
结局指标
主要结局
C0 of tacrolimus after the initial dose, the percentage of out-of-range C0 after initial dose, the number of dose adjustments made to achieve therapeutic range (5-10 ng/ml) and the dose requirement to reach therapeutic range
时间窗: not less than three days after initial dose and not more than one month
次要结局
- acute rejection rate within two weeks after transplantation(within two weeks after transplantation)
- serum creatinine at fourteen days after transplantation(fourteen days after transplantation)
研究者
研究点 (2)
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