Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Tacrolimus Target Trough Level Maintenance
研究概览
简要总结
Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.
详细描述
The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.
The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.
The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults undergoing liver and/or kidney transplantation
排除标准
- •transplant patients with contraindications to tacrolimus
研究组 & 干预措施
Standard of Care
Standard of Care Tacrolimus Drug Dosing
干预措施: Tacrolimus (Drug)
Phenotypic Precision Medicine (PPM)
PPM-based Computation Assisted Drug Dosing
干预措施: PPM-based Computation Assisted Drug Dosing (Other)
Phenotypic Precision Medicine (PPM)
PPM-based Computation Assisted Drug Dosing
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Tacrolimus Target Trough Level Maintenance
时间窗: 2 weeks
Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
次要结局
未报告次要终点
