What this study is
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.
What's being tested
- Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients
Intervention · BIOLOGICAL
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.
Study details
- Official title
- Optimization of Tacrolimus Management During Pregnancy: Modeling of Unbound and Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
- Sponsor
- Baylor Research Institute
- Conditions
- Unbound Tacrolimus in Pregnant Uterus Transplant Recipients · Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients
- Enrolling
- 55 people
- Starts
- 2026-05-31
- Est. completion
- 2028-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Uterus transplant recipient
- 18 to 50 years of age
- Receiving tacrolimus for immunosuppression.
You can't join if
- Individuals who have not had a uterine transplant
- Individuals over 50 years old
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBaylor University Center of Dallas
Dallas, Texas, United States
Study team
Sponsor
Baylor Research Institute
Study ID 026-140
Principal investigator
Nicole Wilson, Pharmacist
Baylor Scott and White Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.