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.
Uterus transplant recipient
18 to 50 years of age
receiving tacrolimus for immunosuppression.
Individuals who have not had a uterine transplant
individuals over 50 years old
Uterus transplant recipient over 18 years of age receiving tacrolimus for immunosuppression.
Case-only
Prospective
Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients
Biological/VaccineDevelop 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.
Understanding Tacrolimus Levels in Pregnancy
Develop a joint non-linear mixed effect population pharmacokinetic model describing bound and unbound tacrolimus pharmacokinetics in pregnant subjects.
Adjusting Tacrolimus Blood Levels by Trimester
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
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
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Baylor Research Institute
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborator
University of Washington
Collaborator
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