EUCTR2004-000655-41-ES进行中（未招募）1 期
A one-year, multicenter, open-label, feasibility study to evaluate the safety and the efficacy of FTY720 5mg introduction and CNI elimination in adult maintenance renal transplant reicpients maintained on a triple immunosuppressive regimen with either MPA or mTOR inhibitor
ovartis Farmacéutica S.A0 个研究点目标入组 0 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •male and female adults between 6 and 60 months post renal transplantation, maintained for the last 6 months on the same triple immunussupressive regimen : CNI + MPA + corticosteroids or CNI + mTOR + corticosteroids
- •stable renal function and no history of rejection
- •PRA <10% pre-transplantation
- •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
- •patient at high immunological risk of rejection
- •pulse rate < 50bpm at screening
- •presence or history of second or third degree AV block
- •history of cardiac arrest
- •history of malignancy
- •systemic infection within 2 weeks prior to start study medication
- •HIV or hepatitis B surface Ag positive
研究者
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