NCT00229138已完成4 期
A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- renal function at 6 months posttransplant as measured by glomerular filtration rate
研究概览
简要总结
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
- •The renal cold ischemic time (CIT) must be <30 hours
- •The age of the donor must be between 10 and 65 years
- •Exclusion Criteria
- •Patients who have previously received an organ transplant
- •Patients who are recipients of a multiple organ transplants
- •Recipients of non heart-beating donor organs
- •ABO incompatibility against the donor
- •Other protocol-defined exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
reduced Tacrolimus
Experimental
干预措施: EC-MPS, Tacrolimus (Drug)
Reference Tacrolimus
Active Comparator
干预措施: EC-MPS, Tacrolimus (Drug)
结局指标
主要结局
renal function at 6 months posttransplant as measured by glomerular filtration rate
时间窗: 6 months
次要结局
- Safety as measured by incidence of adverse events
- Gastrointestinal tolerability as measured by gastrointestinal
- Renal function as measured by calculated creatinine clearance
- symptom rating scale (GSRS) at various time points
- Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
- Cockcroft-Gaultand serum creatinine at 6 months
- Effects on glucose metabolism at months 3 and 6 after transplantation.
研究者
研究点 (1)
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