Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus

Novartis0 个研究点目标入组 132 人开始时间: 2004年3月1日最近更新: 2011年2月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 132
主要终点: Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

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/kidney-pancreas transplant received at least six months previously;
•Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

排除标准

•Subjects expected to discontinue tacrolimus 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

Incidence of biopsy proven acute rejection
Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
Quality of life related to GI symptoms (GIQLI scale)
Full blood count
Gastrointestinal Adverse Events (check-list)

研究者

发起方

Novartis

申办方类型

Industry

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