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Could a Once-Daily pill make life easier for kidney transplant patients?

NCT ID NCT03979365

Disease control Sponsor: Mayo Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 261 kidney transplant patients to see if taking a once-daily anti-rejection drug (Envarsus XR) leads to fewer side effects and better medication adherence compared to the standard twice-daily drug. Patients reported symptoms like trembling, muscle cramps, and gum swelling. The goal was to improve quality of life without changing the need for lifelong anti-rejection medication.

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

261 people

The number who actually took part.

Started

Jul 2019

Finished

Mar 2022

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: * Patient is an adult (18 years of age or older). * Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient's transplant care team. * Patient is a recipient of a deceased or living donor kidney transplant. * Patient is able to comply with study procedures for the entire length of the study. * Patient has been informed about the study survey and has signed an informed consent form. Exclusion Criteria: * Patient is unable or unwilling to complete study patient reported outcome questionnaires. * Patient is currently receiving azathioprine * Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus) * Patient is currently receiving an belatacept * Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant * Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.

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As listed by the trial registrant

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

Kidney transplant recipients

Contacts and locations

Locations

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

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