IRCT2013012612274N1已完成3 期
Evaluation of the Clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Have signed the informed consent form; Have a BMI (body mass index) between 18.5 and 24.9; Are male or females between the age of 18 and 60years old; Are going to be transplanted (kidney) for the first time; Are willing to begin and continue treatment with the triple scheme (corticosteroids, cyclosporine and Suprimun/Cellcept®); Are going to benefit from this triple scheme; Are in good general medical conditions; Agree to use birth control methods; Have ABO compatibility; Have low immunologic risk (PRA < 20%, high HLA compatibility); Are taking MMF with a total dose of 2 gr/d (4 tablets); Are receiving transplant from non-relative and alive donors.
- •Exclusion Criteria :
- •Receive Mycophenolate Mofetil from another brandname; Have active Hepatitis B or C; Is intolerant to any of the drugs of the triple scheme; Have any medical condition that can interfere with the normal follow up of the study; Has a history of MI, life-threatening arrhythmia or CVA in the last 6 month , history of malignancy, pregnancy and breastfeeding; Have participated in another clinical study 3 months ago or less before the selection visit; Any induction Therapy (ATG , IL2 receptor inhibitor) before or during the surgery; Any renal rejection with non-relative reason to Mycophenolate drug during 48h after the surgery.(Vascular rejection, urological rejection); Taking medications that interfere with the action of the drug, including: Magnesium and Aluminum Hydroxide, Cholestyramine, phenytoin , diltiazem and Probenecid, any live vaccines; Are being transplanted for 2nd or 3rd time, or from cadaver; Be addicted to alcohol or illegal drugs;Be HIV positive
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- 未提供
研究者
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