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Kidney transplant study tests Once-Daily pill to replace Twice-Daily dosing

NCT ID NCT04773392

Disease control Sponsor: University of Southern California 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether a once-daily extended-release form of tacrolimus (Envarsus XR) combined with azathioprine could work as well as the standard twice-daily tacrolimus plus mycophenolate in preventing kidney transplant rejection. The trial planned to enroll 20 adults receiving a first kidney transplant, but it was terminated early. Because of the small size and early stop, no firm conclusions can be drawn about the safety or effectiveness of the simplified regimen.

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 XR and immediate-release forms), azathioprine, mycophenolate mofetil/mycophenolic acid, basiliximab, rabbit anti-thymocyte globulin
What this could lead to
If successful, this could simplify post-transplant medication by using a once-daily pill instead of twice-daily, potentially improving convenience and adherence.
What could go wrong
The trial was terminated early and enrolled only 20 people, so results are very limited. It is not known if the simplified regimen is as safe or effective as the standard approach.

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

20 people

The number who actually took part.

Started

Nov 2021

Finished

Feb 2024

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 85 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: * De- Novo Kidney transplant patients between 18 and 85 years old * Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient * Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20% Exclusion Criteria: * Repeat kidney transplant recipients * cPRA \>20% * rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction * Crossmatches deemed positive by accepting physician * Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing. * Receipt of desensitization protocols * History of skin cancer * Recipient of multi-organ or dual kidney transplants * For any condition, in which the investigator's opinion makes the subject unsuitable for study

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Kidney transplant rejection Kidney transplantation

Contacts and locations

Locations

  • University of Southern California

    Los Angeles, California, 90033, United States

More trials for these conditions

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