Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- I. Percentage of tacrolimus levels in range after transplantation
研究概览
简要总结
Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus
详细描述
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Background and Rationale- The novel once-daily extended-release tacrolimus (ERT) has been shown to be non-inferior to twice-daily tacrolimus (TDT) during induction immunotherapy for kidney transplantation. The ERT (Envarsus) has a MeltDose technology that allows for steadier absorption of tacrolimus throughout the entire gastrointestinal tract. This drug has decreased peak to trough fluctuation. This decrease in variability and stabilized trough level should allow for easier achievement of target drug levels with fewer clinic visits and drug level assays.
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Objective
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To assess the safety of ERT versus TDT and effectiveness in achieving tacrolimus trough therapeutic range during the first 6 months after transplantation
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Primary End-Point
i. Ability to achieve center specific target tacrolimus trough levels at the determined intervals after transplantation.
- Percent of levels in range 2. As most levels occur in the first 6 months, a 6-month time frame will be used for the primary analysis.
c. Secondary End-Points i. Number of dose adjustments required ii. Time in therapeutic range for tacrolimus trough levels during intervals after transplantation based on the Rosendaal Method
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age 18-70
- •Receiving a kidney transplant at Sentara Norfolk General Hospital
- •Able to give informed consent
排除标准
- •Multi-organ transplant
- •Previous functioning transplant
- •Prior surgery to the gastrointestinal tract that alters the normal anatomy with the exception of cholecystectomy
- •Women of childbearing potential who cannot or are unwilling to maintain adequate contraception during the course of this study.
研究组 & 干预措施
Envarsus
Once-daily extended-release tacrolimus
干预措施: Tacrolimus (Drug)
Prograf
twice-daily tacrolimus
干预措施: Tacrolimus (Drug)
结局指标
主要结局
I. Percentage of tacrolimus levels in range after transplantation
时间窗: 6 Months
Labs will be drawn at weekly clinic visits for the first month, every other week for the second month, then a minimum of monthly through 6 months post transplant. Labs drawn will include tacrolimus level to determine if trough levels are within target ranges according to the site's center specific tacrolimus protocol.
次要结局
- II. Time in therapeutic range for tacrolimus trough levels during intervals after transplantation based on the Rosendaal Method(6 Months)