NCT00007059已完成不适用
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
National Center for Research Resources (NCRR)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 1998年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation.
II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
详细描述
PROTOCOL OUTLINE:
Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant
- •Kidney transplant recipients will serve as study controls
- •-Prior/Concurrent Therapy--
- •No concurrent bile acid sequestrants
- •No mycophenolate mofetil as part of rescue therapy regimen
- •No concurrent albumin replacement therapy
- •-Patient Characteristics--
- •Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL
- •Not pregnant
- •No mental incompetency
- •No prisoners or parolees HIV negative
- •No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum
排除标准
- 未提供
研究者
研究点 (1)
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