NCT03347357已完成4 期
Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome
Shandong University0 个研究点目标入组 28 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- change of plasma concentration of Tacrolimus
研究概览
简要总结
the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients have been diagnosed with nephrotic syndrome;
- •age range: 1 month to 18 years old
- •tacrolimus used as part of regular treatment
排除标准
- •expected survival time less than the treatment cycle;
- •patients with other factors that researcher considers unsuitable for inclusion.
研究组 & 干预措施
tacrolimus
Experimental
干预措施: Tacrolimus (Drug)
结局指标
主要结局
change of plasma concentration of Tacrolimus
时间窗: at 1,2,3,6,9,12 hours after oral administration
To detect the plasma concentrations of Tacrolimus after oral administration
次要结局
未报告次要终点
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University
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