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Heart transplant patients may soon take just one pill a day

NCT ID NCT03373227

Disease control 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a once-daily version of the anti-rejection drug tacrolimus (Envarsus) works as well as the standard twice-daily version (Prograf) in heart transplant recipients. Fifty adults who had a heart-only transplant were enrolled. The goal was to see if the easier once-daily dosing could improve medication compliance and reduce the risk of organ rejection or graft failure.

What this could mean

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

Active substance
tacrolimus (Envarsus and Prograf)
What this could lead to
If successful, this could show that a once-daily pill is as effective as twice-daily dosing, making it easier for heart transplant patients to stick to their medication schedule and potentially reduce rejection risks.
What could go wrong
This is a small, early-phase study with only 50 participants, so results may not apply to all patients. The study is also open-label, meaning both patients and doctors know which drug is given, which can introduce bias.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Dec 2017

Finished

Dec 2023

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 to 80 years

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: * Male or female, ≥ 18 years of age * Able to comply with medication regimen * Subjects must have the capacity to understand and sign the informed consent form * Heart-only transplant recipients Exclusion Criteria: * Subject currently enrolled in another interventional research trial * History of hypersensitivity/adverse reaction to tacrolimus * Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf) * Simultaneous multiple organ transplant recipients * Liver transplant recipients / candidates

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Conditions

The condition(s) this trial relates to.

Patient Compliance transplant rejection

As listed by the trial registrant

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

Compliance, patient Graft failure Heart transplant rejection

Contacts and locations

Locations

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.