Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
研究概览
简要总结
Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
- •Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit
排除标准
- •Evidence of rejection on routine six month post-transplant biopsy
- •Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
- •Are or are planning to become pregnant, due to inability to take mycophenolate
- •Are marginally housed, due to concerns regarding routine follow-up
- •Are actively participating in a different interventional trial that may affect immunosuppression dosing
- •Are unwilling to consent to participate
- •Institutionalized individuals or prisoners
- •Are actively abusing illicit drugs or alcohol
- •Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
- •Have cognitive impairment prohibiting participation in the study
研究组 & 干预措施
Body surface area-based mycophenolate dosing
Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.
干预措施: Mycophenolate Mofetil (Drug)
Standard (fixed) dosing
Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
时间窗: 6 months
Assess the ratio of participants screened to enrolled into the study
次要结局
- Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate(6 months)
- Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate(6 months)