NCT00170885已完成4 期
Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
研究概览
简要总结
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
- •The renal cold ischemic time must be < 36 hours.
- •The age of the donor must be between 15 and 65 years.
排除标准
- •Patients who are recipients of multiple organ transplants, including more than one kidney
- •Patients who have previously received an organ transplant which failed within one year
- •Patients with current panel reactive T-cell antibody titers of 50% or more
- •Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
次要结局
- Metabolic control: lipids, glycaemic control, proteinuria, enzymes
- Ultrasound ejection fraction
- Major adverse cardiovascular events
- Pharmacokinetics (PK)
- Count of CD4 and CD8 positive lymphocytes
研究者
研究点 (1)
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