MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence, severity and relationship of adverse events (AEs) to the Study medication
研究概览
简要总结
The purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or intervention(s) additional to the daily practice were performed.
详细描述
A single center, observational, open-label, longitudinal, prospective study combined with retrospective data collection for 12 de novo renal transplant patients. Ten patients were prospectively followed for 12 months after receiving MyOra® (mycophenolate mofetil) and two patients were previously on MyOra® (mycophenolate mofetil), thus their data was retrospectively collected from their hospital records and all relevant workup tests results. Outcomes include occurrence of AEs and proportion of patients with normal graft function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient received de novo renal transplant
- •Patient treated with MyOra® according to the attending physician's judgment (either post-transplant or induction)
- •Patient provided written informed consent
排除标准
- •Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®
结局指标
主要结局
Incidence, severity and relationship of adverse events (AEs) to the Study medication
时间窗: 12 months
Rate of AEs, SAEs and laboratory tests abnormalities will be calculated
次要结局
- Proportion of patients with normal graft function(12 months)