NCT03555448终止4 期
Once a Day Immunosuppression Regimen: Outcomes and Compliance
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
研究概览
简要总结
The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability, and lower biopsy proven rejection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years old
- •Kidney transplant recipient
- •Thymoglobulin induction
排除标准
- •Non-renal organ transplant
- •Combined organ transplant
- •Inability to receive Envarsus after transplant
- •Discharged to acute care facility after transplant
研究组 & 干预措施
Once daily regimen
Active Comparator
Once daily medication regimen (Envarsus and azathioprine)
干预措施: Once daily immunosuppression regimen (Drug)
Twice daily regimen
Active Comparator
Twice daily medication regimen (Tacrolimus and mycophenolic acid)
干预措施: Twice daily immunosuppression regimen (Drug)
结局指标
主要结局
Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
时间窗: 3 months and 12 months post transplant
BAASIS Survey
次要结局
- Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months(3 months and 12 months post transplant)
- Composite Endpoint Measurement(12 months)
研究者
研究点 (1)
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