A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rejection
研究概览
简要总结
This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.
详细描述
This study aims to include Hispanics who have undergone a renal transplant to determine the specific outcome after renal transplantation, assuming that ethnic groups require different immunosuppressant regimens. Trough levels in transplant recipients determine the dosing requirements for Tacrolimus and Cyclosproine. It has been recently found, however, that testing cyclosporine levels in the blood 2 hours after taking cyclosporine is more effective in dosing cyclosprine for renal transplant patients than trough levels. The specific study aims include comparing the cyclosporine monitoring in patients with trough and C2 levels, and adjusting immunosuppression based on C2 levels.
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
- •Cadaveric or Living Donors
- •18 years old or greater
- •Primary renal transplants
- •Hispanic ethnicity
排除标准
- •Prior renal transplant
- •Multi-organ transplant
- •Recipient with history of Diabetes Mellitus
- •PRA > 20%
- •Cold Ischemia Time > 24 hours
研究组 & 干预措施
Neoral
Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
干预措施: Neoral (Drug)
Prograf
Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
干预措施: Prograf (Drug)
结局指标
主要结局
Rejection
时间窗: 6 months post-transplant
次要结局
- Renal Function(6 months post-transplant)
- Lipid Levels(6 months post-transplant)
- Post-transplant Diabetes Mellitus(6 months post-transplant)