NCT01300416已完成不适用
Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 9
- 主要终点
- To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.
研究概览
简要总结
This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.
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
- •Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
- •Eligible to convert to myfortic because of GI complaints or not currently experiencing GI complaints and stable on current immunosuppressive regimen.
- •At least 18 years of age;
- •Willing to provide written informed consent; and
- •Able to meet all study requirements including completing paper questionnaires and completing two study visits.
排除标准
- •GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
- •Breast-feeding or pregnant woman.
- •Patients with psychiatric illness.
- •Underlying acute medical intervention or hospitalization
- •Receiving investigational drug within 30days prior to study.
结局指标
主要结局
To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.
时间窗: 4-6 weeks
次要结局
- To identify and evaluate quality of life and impact on symptom severity based on patients perception.(4-6 weeks)
研究者
研究点 (9)
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