Unbound Tacrolimus in Pregnant Uterus Transplant Recipients, Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALModeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients
Develop an estimating equation to correct tacrolimus whole blood concentrations given the known increase in the unbound tacrolimus concentration in pregnant patients to obtain a more accurate picture of active tacrolimus exposure (unbound drug) in pregnant uterus transplant recipients.
Sponsors
Baylor Research Institute
Children's Hospital Medical Center, Cincinnati
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Inclusion criteria
* Uterus transplant recipient * 18 to 50 years of age * receiving tacrolimus for immunosuppression.
Exclusion criteria
* Individuals who have not had a uterine transplant * individuals over 50 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Understanding Tacrolimus Levels in Pregnancy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusting Tacrolimus Blood Levels by Trimester | 2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy | Create an equation to adjust whole blood tacrolimus concentrations for changes in drug binding during each trimester at the point of care |
| 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 | Correlate clinical outcomes with estimated unbound tacrolimus concentrations from uterus transplant recipients during each trimester and outside of pregnancy using whole blood trough concentrations and the model developed in Outcome 1 |
Countries
United States
Contacts
CONTACTAshley McAllister
CONTACTTaryn Kruse
PRINCIPAL_INVESTIGATORNicole Wilson, Pharmacist
Baylor Scott and White Health
Outcome results
None listed