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New formula aims to improve drug safety in pregnant transplant patients

NCT ID NCT07422012

Knowledge-focused Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will develop a formula to more accurately measure active tacrolimus levels in pregnant women who have had a uterus transplant. Tacrolimus is an immunosuppressant drug that prevents organ rejection, but pregnancy changes how the body processes it. Researchers will analyze blood samples from 55 participants to create a model that adjusts for these changes, potentially leading to safer dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tacrolimus
What this could lead to
If successful, this could lead to safer and more effective tacrolimus dosing during pregnancy for uterus transplant recipients.
What could go wrong
This is an early modeling study, not a treatment trial. The formula may not improve outcomes or may be too complex for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Uterus transplant recipient over 18 years of age receiving tacrolimus for immunosuppression.

Ages

18 to 50 years

Sex

Female participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Uterus transplant recipient * 18 to 50 years of age * receiving tacrolimus for immunosuppression. Exclusion Criteria: * Individuals who have not had a uterine transplant * individuals over 50 years old

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unbound tacrolimus in pregnant uterus transplant recipients Whole blood tacrolimus in pregnant uterus transplant recipients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor University Center of Dallas

    Dallas, Texas, 75246, United States