TCTR20170206004尚未招募1 期
Therapeutic drug monitoring of mycophenolic acid and validation of limited sampling strategies for the estimation area under the mycophenolic acid concentration-time curve in Thai pediatric renal transplant recipients at Siriraj hospital
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
- Observational
入排标准
- 年龄范围
- 0 Years 至 18 Years（—）
- 性别
- All
入选标准
- •1. Renal transplant recipients who aged under 18 years old
- •2. Renal recipient who underwent transplantation for at least 3 months and follow-up at Siriraj hospital
- •3. Renal recipient who on stable dose of MPA (MMF or EC-MPS) for at least 1 week
- •4. Renal recipient who voluntarily given consent to participate the study by their parents or caregiver and additional assent for children 7-18 years old
排除标准
- •1.Renal recipient who has hematological abnormalities within 3 months:
- •- Hemoglobin < 5 gm/dl, or
- •- Platelet < 100,000 cell/mm3
- •2.Renal recipient who has concomitant drug use which might change the PK properties of MPA such as omeprazole, metronidazole, norfloxacin, pantoprazole, rifampin, antacids, cholestyramine, rabeprazole, esomeprazole, lansoprazole, dexlansoprazole, colestipol, colesevelam, activated charcoal, cyclosporine
- •3.Renal recipient who has condition that affect PK od MPA such as gastrointestinal diseases, liver dysfunction
研究者
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