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Once-a-day transplant drug may simplify life for kidney and liver patients

NCT ID NCT02882828

Disease control Sponsor: University Hospital, Limoges 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 134 kidney or liver transplant patients who switched from taking tacrolimus twice a day (Prograf) to once a day (Envarsus). Researchers measured drug levels in the blood before and after the switch to see if the once-daily version provides similar exposure. The goal is to make dosing easier and more convenient for patients.

What this could mean

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

Active substance
tacrolimus (Prograf and Envarsus)
What this could lead to
If successful, this could show that switching to once-daily Envarsus maintains stable drug levels, making it easier for transplant patients to manage their medication.
What could go wrong
This is a small, completed Phase 4 study focused on drug levels, not long-term outcomes. Results may not apply to all transplant patients or guarantee better health.

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

134 people

The number who actually took part.

Start date

Oct 2016

Finished

Mar 2020

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: 1. Adult (≥ 18 year-old) male and female patients 2. Recipient of a single kidney or liver allograft 3. Patient transplanted for more than 2 weeks and less than 1 year at enrolment 4. Patient with stable Prograf® dose, defined by the following criteria: * Criterion 1: unchanged Prograf® dose for at least one week; if not, apply criterion #2 * Criterion 2: unchanged Prograf® dose since the last two therapeutic drug monitorings (TDM) 5. Patient for whom the decision is made to switch from Prograf® to Envarsus® 6. Written informed consent obtained prior to any study-related procedure 7. Patient with tacrolimus C0 between 4 and 12 µg/L at V1 8. Patient with hematocrit \> 27% at V1 Exclusion Criteria: 1. Patient presenting any contra-indication to tacrolimus according to the summary of product characteristics (SmPC) of Envarsus® 2. Recipient of any transplanted organ other than kidney or liver 3. Patient treated by Prograf® for less than 7 days at enrolment 4. Patient previously treated by any other investigational agent if it is not stopped at least 7 days prior to enrolment 5. Pregnant or lactating woman (based on declaration) 6. Patient under judicial protection 7. Patient incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.

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As listed by the trial registrant

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

Allograft

Contacts and locations

Locations

  • AP-HP

    Paris, France

  • Limoges Hospital

    Limoges, 87 042, France

  • University Hospital of Amiens

    Amiens, France

  • University Hospital of Bordeaux

    Bordeaux, France

  • University Hospital of Lille

    Lille, France

  • University Hospital of Poitiers

    Poitiers, France

  • University Hospital of Reims

    Reims, France

  • University Hospital of Rouen

    Rouen, France

  • University Hospital of Tours

    Tours, France

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