A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Dosage of EC-MPS or MMF over time
研究概览
简要总结
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age or older.
- •The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
- •Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
- •Able to provide informed consent.
- •Able to self-administer the ITAS compliance instrument (6 questions).
排除标准
- •The recipient of multiple organ grafts or prior non-kidney graft.
- •Enrolled or plans to enroll in an investigational clinical trial.
- •Not likely to have up to 5 year follow-up data available for this study.
结局指标
主要结局
Dosage of EC-MPS or MMF over time
时间窗: 60 months
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
次要结局
- Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications(60 months)
- Center Practices(60 months)
- The incidence of selected Adverse Events(60 months)
- Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death(60 months)