NCT00529269已完成4 期
Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index.
研究概览
简要总结
This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
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 1 month prior to study enrollment
- •Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment
- •Eligible to convert to enteric-coated mycophenolate sodium (EC-MPS) 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
- •Able to meet all study requirements including completing electronically-administered questionnaires and completing two study visits.
排除标准
- •GI symptoms assumed or known not to be caused by MPA (Mycophenolic acid) therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- •Acute rejection < 1 week prior to study enrollment
- •Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
- •Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
- •Undergoing acute medical intervention or hospitalization
- •Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
- •Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
- •Other protocol-defined inclusion /exclusion criteria may apply.
结局指标
主要结局
Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index.
次要结局
- Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL.
研究者
研究点 (3)
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