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New drug may protect kidneys in lung transplant patients

NCT ID NCT04469842

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving a long-acting version of the anti-rejection drug tacrolimus early after a lung transplant can help protect kidney function while still preventing organ rejection. About 48 adults who have recently received a lung transplant will be randomly assigned to receive either the long-acting drug or the standard version. The goal is to see if the new drug is safe, well-tolerated, and leads to fewer side effects like kidney damage.

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.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 48 people

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

Started

Dec 2023

Expected to finish

Dec 2027

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Status-post single or bilateral lung transplantation * Participant is able to give informed consent for participation in the study. * Male or female age 18 years or above. * Actively receives care at VUMC and is adherent with medical therapies. Exclusion Criteria: * History of prior organ transplantation * History of tacrolimus use prior to transplantation * Intolerance of tacrolimus (that precludes use) * Having DSA pre-transplant (Positive virtual crossmatch) * Active infection with Hepatitis B or C * Active infection with Human Immunodeficiency Virus (HIV) * Baseline AST / ALT \> three times upper limit normal * Primary graft dysfunction grade 3 at 72 hours * Acute kidney injury during index hospitalization that does not resolve to two times the pre-transplant baseline value. * Contraindication to PO (per os) intake of medications * Impaired GI absorption (defined as sublingual administration of IR-tacro) * History of frequent headaches * Seizure history * Cannot provide consent (at least verbally) * Pregnancy or breast-feeding * Participation in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

disease related to solid organ transplantation

As listed by the trial registrant

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

Lung transplant; complications

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

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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