Baylor University Center of Dallas
Dallas, Texas, 75246, United States
Not Yet Recruiting
NCT Number: NCT07422012
Tacrolimus in Pregnancy
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients
BiologicalDevelop 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.
Primary outcomes
-
Understanding Tacrolimus Levels in Pregnancy
Time frame: 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 outcomes
-
Adjusting Tacrolimus Blood Levels by Trimester
Time frame: 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
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Ashley McAllister
CONTACT
Taryn Kruse
CONTACT
Sponsors and collaborators
Lead sponsor
Baylor Research Institute
Other
Collaborators
- Children's Hospital Medical Center, Cincinnati
- University of Washington
Registry information
Official study title
Optimization of Tacrolimus Management During Pregnancy: Modeling of Unbound and Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Feb 19, 2026
- Registry last updated
- Apr 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.