NCT00149903已完成3 期
Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
研究概览
简要总结
Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal 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
- Double
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 first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
- •treated with cyclosporine and corticosteroids 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
- •Patients who have received an investigational drug within four weeks prior to study entry
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
次要结局
- Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
- Other variables of efficacy: chronic rejection, graft loss, death.
- Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
研究者
研究点 (1)
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