NCT00171496已完成4 期
A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 693
- 主要终点
- Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
研究概览
简要总结
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second transplant, cadaveric or living donor
排除标准
- •Multi-organ or dual kidney transplants
- •Panel reactive antibodies >50%
- •Other protocol-defined inclusion/exclusion criteria applied
研究组 & 干预措施
Cyclosporine microemulsion
Experimental
干预措施: Cyclosporine microemulsion (Drug)
Tacrolimus
Active Comparator
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
次要结局
- incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
- percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
- incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)(6 months)
- Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
- percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
- Blood pressure at Months 3& 6 post-transplantation
- incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
研究者
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