EUCTR2004-004377-28-SE进行中（未招募）不适用
A two-year extension to a one-year, multicenter, partially blinded, double-dummy, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral and corticosteroids versus mycophenolate mofetil (MMF, CellCept) combined with full-dose Neoral and corticosteroids, in de novo adult renal transplant recipients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 690
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a)The patient has given written informed consent to participate in the extension study.
- •b)The patient has completed the core study (through 12 months post-transplantation) and has been maintained on study medication (FTY720/Neoral or MMF/Neoral in combination with corticosteroids), consistent with their original randomization, at their Month 12 visit.
- •c)Females capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with any medical or psychosocial condition which the investigator believes would hinder compliance with the study requirements.
研究者
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