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Tacrolimus in Pregnancy

NCT07422012 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Nicole Wilson, Pharmacist · Baylor Scott and White Health

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-02-29
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07422012 on ClinicalTrials.gov