A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Incidence of All Biopsy Proven Acute Rejection.
研究概览
简要总结
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
详细描述
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 75 years of age.
- •Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.
排除标准
- •Patient previously received or is receiving an organ transplant other than kidney.
- •Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
- •Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
- •Uncontrolled concomitant infection or other unstable medical condition.
- •Patients that received an investigational drug in the 30 days prior to transplant.
- •Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
- •Receiving chronic steroid therapy at the time of transplant.
- •History of malignancy in last 5 years.
- •Pregnant or lactating.
研究组 & 干预措施
Mycophenolic Acid (Myfortic) Preload
Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
干预措施: Mycophenolic Acid (Myfortic) (Drug)
Mycophenolic Acid (Myfortic) Standard
Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
干预措施: Mycophenolic Acid (Myfortic) (Drug)
结局指标
主要结局
Incidence of All Biopsy Proven Acute Rejection.
时间窗: 12 months
Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
次要结局
- Patient and Allograft Survival 12 Months(12 months)
- GI Toxicities(12 months)
- Renal Function at 12 Months(12 months)
- Incidence of Post Transplant Infections(12 months)
研究者
Rita Alloway
PharmD, FCCP
University of Cincinnati