跳至主要内容
临床试验/NCT03527238
NCT03527238已完成2 期

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

University of Florida3 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2018年9月21日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Standard of Care Tacrolimus Drug Dosing

干预措施: Tacrolimus (Drug)

Phenotypic Precision Medicine (PPM)

Experimental

PPM-based Computation Assisted Drug Dosing

干预措施: PPM-based Computation Assisted Drug Dosing (Other)

Phenotypic Precision Medicine (PPM)

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验