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Can a Once-Daily form of tacrolimus spare liver transplant patients from side effects?

NCT ID NCT05242315

Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

After a liver transplant, patients take tacrolimus to stop their immune system from rejecting the new organ, but the drug can cause kidney problems, high blood pressure, diabetes, and other side effects. Researchers at the University of Alberta are comparing a once-daily extended-release form called Envarsus with the standard immediate-release form in about 94 adults who recently received a liver transplant. The trial tracks rejection episodes, kidney function, and other complications to see whether the extended-release version is safer and works as well.

What this could mean

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

Active substance
extended-release tacrolimus (Envarsus), an immunosuppressant taken after liver transplant
What this could lead to
If extended-release tacrolimus causes fewer side effects, it could give liver transplant recipients a gentler option for preventing organ rejection.
What could go wrong
This is a Phase 4 comparison at a single centre, so results may not apply everywhere. Both formulations contain the same drug, and any differences in side effects or outcomes may turn out to be small.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 94 people

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

Started

May 2022

Expected to finish

Feb 2034

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: \- Adult individuals transplanted at the University of Alberta Exclusion Criteria: * Individuals with congenital long QT syndrome * Patients with elevated bilirubin \> 100 umol/L post-LT (at day 3) * Patients with chronic kidney disease (eGFR \< 45 ml per minute per 1.73 m2) * Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors. * Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome cardiovascular disorder kidney failure metabolic syndrome X transplant rejection prevention target

As listed by the trial registrant

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

Cardiovascular diseases Immunosuppressant adverse reaction Liver transplant; complications Metabolic syndrome Renal insufficiency

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

  • Univerity of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

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