NCT00101738已完成3 期
Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 85
- 主要终点
- Calculated glomerular filtration rate after 12 months treatment
研究概览
简要总结
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 to 75 years.
- •Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.
排除标准
- •Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
- •Kidneys from non-heart beating donors or HLA identical living related donors.
- •ABO incompatibility against the donor.
结局指标
主要结局
Calculated glomerular filtration rate after 12 months treatment
次要结局
- Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
- Patient and graft survival after 12 months.
- Incidence of AEs and SAEs after 3 and 12 months.
- Blood pressure, lipids and glucose profiles after 3 and 12 months.
- Percentage of patients free of steroids at 12 months
研究者
研究点 (85)
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