Optimization of Tacrolimus Management During Pregnancy: Modeling of Unbound and Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Understanding Tacrolimus Levels in Pregnancy
研究概览
简要总结
To create a formula that adjusts tacrolimus blood levels. This is needed because pregnant patients have higher levels of unbound tacrolimus. The adjusted formula will give a more accurate measure of the active drug in pregnant uterus transplant patients.
详细描述
A non-linear mixed effects model describing tacrolimus exposure in pregnant and non-pregnant subjects will be developed using prospectively collected de-identified data from pregnant uterus transplant recipients at BUMC.
The model will be analyzed to develop an estimating equation for tacrolimus unbound concentrations from whole blood concentrations, albumin and hematocrit during each trimester of pregnancy.
The estimating equation will then be applied to data from uterus transplant recipients enrolled in this study and retrospectively to uterus recipients transplanted since October 2020 to clinically validate the findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uterus transplant recipient
- •18 to 50 years of age
- •receiving tacrolimus for immunosuppression.
排除标准
- •Individuals who have not had a uterine transplant
- •individuals over 50 years old
研究组 & 干预措施
Pregnant Individuals
Individuals who had a uterus transplant that are using tacrolimus during pregnancy.
干预措施: Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients (Biological)
结局指标
主要结局
Understanding Tacrolimus Levels in Pregnancy
时间窗: 2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy
Develop a joint non-linear mixed effect population pharmacokinetic model describing bound and unbound tacrolimus pharmacokinetics in pregnant subjects.
次要结局
- Adjusting Tacrolimus Blood Levels by Trimester(2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy)
- Linking the Mixed Pharmacokinetic Model and the Equation to Adjust Whold Blood Tacrolimus Concentrations to Active Tacrolimus Levels During and After Pregnancy(1 week postpartum, 4 weeks, 5 weeks and 6 weeks postpartum)