NCT00238992已完成3 期
A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo 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
- 144
- 主要终点
- biopsy proven acute rejection incidence at 1 year post-transplantation
研究概览
简要总结
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.
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 patients undergoing first kidney transplant.
- •Patients aged 18 -70 years.
- •Patients receiving an ABO identical or compatible graft.
排除标准
- •Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
- •Positive HBsAg test
- •Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
biopsy proven acute rejection incidence at 1 year post-transplantation
次要结局
- Incidence of biopsy proven acute rejection episodes at 6 months
- Incidence of treated rejection episodes at 6 months and 1 year
- Incidence of steroid-resistant episodes at 6 months and 1 year
- Patient and graft survival at 1 year
- Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
- Percentage of patients free from steroids at 6 months and 1 year
- Treatment safety
研究者
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