A Single Centre, Prospective, Open-Label, Parallel Group, Randomized Study to Compare the Gastrointestinal Tolerability of Mycophenolate Mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic) in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period
研究概览
简要总结
The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. The tested hypothesis is that the EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.
详细描述
The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. However, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. An alternate formulation: enteric coated mycophenolate sodium (EC-MPS) was designed to alleviate the severity of upper gastrointestinal side effects. Several trials detailed in the protocol suggest a benefit in GI related health following conversion from MMF to EC-MPS, however we believe that robust data are lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •recipients of liver or kidney or heart or lung or kidney/pancreas transplants
- •at least 1 month post solid organ transplant
- •on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
- •previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
- •age of 18-75 years
排除标准
- •less than 1 month post transplant
- •allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
- •unwillingness or inability to give written consent
- •pregnant or nursing women, or women planning to become pregnant
- •patients with GI symptoms due to reasons other than related to MMF therapy
- •active Post Transplant Lymphoproliferative Disease (PTLD)
- •significant or uncontrolled concomitant infections or other serious medical problems
- •active bacterial, viral or fungal infection
- •inability to self-administer the Quality of Life questionnaires
研究组 & 干预措施
A
MMF
干预措施: MMF (Drug)
B
EC-MPS
干预措施: EC-MPS (Drug)
结局指标
主要结局
The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period
时间窗: 12 months
次要结局
- Analysis and comparison of various Gastrointestinal Symptom Rating and Quality of Life Questionnaire (the GSRS, GIQLI, PGWB,OTE for HRQoL) scores across and within the 2 cohorts.(At months 1, 3, 6, 12 post-study start)
- Incidence and severity of adverse events(months 3, 6, 12)
- Patient survival, graft survival and rejection episodes across the 2 cohorts(months 3, 6, 12)
- Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events(Months 6, 12)