NCT00149968已完成4 期
Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium
研究概览
简要总结
The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Received kidney transplant at least 3 months prior to study enrollment
- •Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
- •Receiving MMF for at least 1 month prior to enrollment
排除标准
- •Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
- •If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- •Acute rejection < 1 week prior to study enrollment
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Myfortic
Experimental
干预措施: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)
结局指标
主要结局
Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium
时间窗: week 0, week 6-8
次要结局
- Gastrointestinal symptoms under MMF-based immunosuppressive therapy(week 0, week 6-8)
- Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life(week 0, week 6-8)
研究者
研究点 (1)
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