Trials / Not Yet Recruiting
Not Yet RecruitingNCT07422012
Tacrolimus in Pregnancy
Optimization of Tacrolimus Management During Pregnancy: Modeling of Unbound and Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (estimated)
- Sponsor
- Baylor Research Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- —
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.
Conditions
- Unbound Tacrolimus in Pregnant Uterus Transplant Recipients
- Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Modeling 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-02-01
- Completion
- 2028-03-01
- First posted
- 2026-02-19
- Last updated
- 2026-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07422012. Inclusion in this directory is not an endorsement.