An Open-label Study of the Pharmacokinetics of Mycophenolic Acid as Myfortic (Enteric-coated Mycophenolate Sodium) When Used in Combination With Prograf (Tacrolimus) and Corticosteroids in Patients Undergoing de Novo Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.
详细描述
Myfortic is approved for use in kidney transplant recipients, and has been prescribed by doctors for liver transplant recipients. No study has been reported to date evaluating the pharmacokinetics of Myfortic in new liver transplant recipients who also take Prograf and corticosteroids. During this six month study, a series of blood samples will be obtained after subjects take Myfortic, Prograf, and corticosteroids.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > or equal to age 18 years
- •Planned to receive tacrolimus and corticosteroid therapy posttransplant
- •Serum creatinine at transplant < or equal to 2.5mg/dL
- •UCSF tumor staging < 8cm total
- •Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the baseline visit and are required to practice a reliable method of contraception for the duration of the study and for no fewer than 6 weeks after completing the study.
- •Signed informed consent form prior to any research assessment
排除标准
- •Induction therapy
- •Requiring dialysis at the time of transplant
- •Organ transplant other than liver
- •Pregnant or nursing females
- •Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female subjects must have experienced 12 consecutive months of amenorrhea.
- •Require any medications that interfere with metabolism of Myfortic (other than corticosteroids)
- •Have a known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or any of its excipients
- •Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
研究组 & 干预措施
Cases
de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium
干预措施: Enteric-coated Mycophenolate Sodium (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: Twelve hour pharmacokinetics at one week, one month, and six months post transplant
Pharmacokinetic time points will be obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, and 12 hours post dose. The exposure (area under the concentration-time curve, AUC μg·h/mL, Cmax ng/mL, and Tmax, hours) of MPA and MPAG will be calculated using non-compartmental analysis.
次要结局
- Safety and tolerability(1 week, 1 month, 6 months)
研究者
R. Mark Ghobrial, MD
Principal Investigator
The Methodist Hospital Research Institute