Patient Reported Outcomes in Renal Transplant Patients Tolerating GI Symptoms Converted to Myfortic (EC-MPS).
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- To determine the incidence of GI related symptoms (GSRS) and the health related quality of life (GIQLI) of renal transplant recipients who are currently tolerating or willing to tolerate MMF.
研究概览
简要总结
Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the objectively measured GI symptom burden and improve GI-related quality of life.
Primary Objective: To determine the incidence of GI-related symptoms and the health related quality of life of renal transplant patients that are currently tolerating MMF. Assessed by GSRS and GIQLI.
Secondary Objective: To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.
详细描述
Investigator originated proposal. Single centre-Foothills Medical Centre, Southern Alberta Transplant Program.
Study design: Three month, longitudinal, open-label, single arm study. Number of study visits: 3 (Baseline, 4-6 weeks, 12 weeks)
Planned sample size :Approx. 110 subjects. Study population will be primary or secondary renal transplant recipients who are stable and are on maintenance immunosuppressive medication which includes MMF.
Gastrointestinal rating scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI)will be the evaluation tool for GI symptoms, completed by study subject via a "touch screen" pc. at baseline, 4-6 week and final 12 week visit.
Study subjects will discontinue MMF following the evening dose on the day of Baseline visit and commence EC-MPS at equimolar doses of subject's current MMF dose.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable primary or secondary renal transplant recipients, males and females. 18-75 years of age.
- •Stable GFR (>30ml/min) Cockroft-Gault equation at time of last clinic visit and at Screening/Baseline visit.
- •Immunosuppression drug regimen that includes MMF(Cellcept)for at least 4 weeks prior to study enrollment.
- •Renal transplant recipients who are tolerating or willing to tolerate GI symptoms related to MMF.
- •Patients willing and capable of given written informed consent for study participation.
排除标准
- •Non-stable renal transplant recipients ( infection, thrombocytopenia,neutropenia, anemia, fluctuating GFR, acute rejection < 1 week prior to study enrollment etc.)
- •Malignancies other than treated basal cell and squamous cell carcinoma of the skin.
- •Other serious medical conditions ( uncontrolled diabetes, peptic ulcers, etc)
- •GI symptoms not related to MMF (ie infectious diarrhoea)
- •Women of childbearing potential who are unwilling to use effective means of contraception.
- •Presence of psychiatric illness that would interfere with study requ1rements.
- •Ongoing acute medical intervention or hospitalization.
- •Patients receiving any investigational drug or having received any investigational drug within 30 days prior to study entry.
结局指标
主要结局
To determine the incidence of GI related symptoms (GSRS) and the health related quality of life (GIQLI) of renal transplant recipients who are currently tolerating or willing to tolerate MMF.
时间窗: 12 weeks
次要结局
- To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to EC-MPS.(12 weeks)
- Adverse events.(12 weeks)
- Renal function as determined by Cockroft-Gault equation.(12 weeks)
- Routine hematological and biochemical bloodwork changes.(12 weeks)