NCT00167947已完成3 期
A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 150 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
研究概览
简要总结
Renal function at 12 months assessed by calculated creatinine clearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age is older than 18 years.
- •End-stage renal disease, with subjects scheduled for kidney transplant.
- •Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- •Other inclusion applies.
排除标准
- •Evidence of active systemic or localized major infection.
- •Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- •Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
- •Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
- •Immunosuppression therapies other than those allowed in the protocol.
- •Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.
- •Other exclusion applies.
研究组 & 干预措施
A
Active Comparator
干预措施: Cyclosporine (Drug)
A
Active Comparator
干预措施: Steroids (Drug)
A
Active Comparator
干预措施: Rapamune (Sirolimus) (Drug)
B
Experimental
干预措施: Cyclosporine (Drug)
B
Experimental
干预措施: Steroids (Drug)
B
Experimental
干预措施: Rapamune (Sirolimus) (Drug)
结局指标
主要结局
To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
时间窗: 6 months
次要结局
未报告次要终点
研究者
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