Tacrolimus in Pregnancy

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT07422012
Status
Not Yet Recruiting

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Conditions

  • Unbound Tacrolimus in Pregnant Uterus Transplant Recipients
  • Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients — 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

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: Pregnant Individuals
    Individuals who had a uterus transplant that are using tacrolimus during pregnancy.

Primary Outcome Measure

Understanding Tacrolimus Levels in Pregnancy [ Time Frame: 2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Center of DallasDallasTexas75246-

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