An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
研究概览
简要总结
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.
详细描述
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.
排除标准
- 未提供
结局指标
主要结局
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
时间窗: during the first 12 months following randomization
Assessment of renal function
时间窗: 12 months post randomization
次要结局
- The proportion of patients experiencing biopsy proven acute rejections
- The total number of biopsy proven, acute rejection episodes, per patient
- The proportion of patients treated for acute rejection
- The time to the first proven acute rejection
- The time to the treatment failure