NCT01476488已完成2 期
Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
研究概览
简要总结
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.
Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ABO-compatible kidney-only transplantation
- •more than 1 year after kidney transplantation
- •5 to 15 years old
- •patients maintained on Prograf
- •tacrolimus level of determined previously: 4 to 20 ng/ml
- •eGFR by Schwartz equation > 50mL/min
排除标准
- •patients with acute rejection within 90 days
- •patients with acute rejection requiring antibody therapy within 6 months
- •patients with more than 2 times of acute rejection within 1 year
- •AST/ALT 2 times more than upper normal limit
- •ABO-incompatible or crossmatch-positive transplantation
- •multiorgan transplantation
研究组 & 干预措施
Advagraf
No Intervention
single group, conversion of prograf to advagraf
干预措施: tacrolimus (Drug)
结局指标
主要结局
Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax
次要结局
- Number of Participants with Adverse Event
研究者
Jongwon Ha
Professor
Seoul National University Hospital
研究点 (1)
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