NCT00171379已完成3 期
Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 162
- 主要终点
- Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
研究概览
简要总结
The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.
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
- Prevention
- 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
- •First or second (single or double) deceased or living donor kidney transplant received at least six months previously;
- •Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
- •Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF
排除标准
- •• Subjects expected to discontinue cyclosporin therapy;
- •Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
- •Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.
结局指标
主要结局
Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
次要结局
- Full blood count
- Gastrointestinal Adverse Events (check-list)
- Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
- Incidence of biopsy proven acute rejection
- Quality of life related to GI symptoms (GIQLI scale)
研究者
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