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Could a Once-Daily pill replace Twice-Daily dosing for young transplant patients?

NCT ID NCT01294020

Disease control Sponsor: Astellas Pharma Europe Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study tested whether children who had received an organ transplant (kidney, liver, heart, lung, or intestine) could safely switch from taking tacrolimus twice a day (Prograf) to a once-daily version (Advagraf). The goal was to see if the once-daily pill provided similar drug levels in the blood and was just as safe over one year. A total of 81 stable pediatric patients were enrolled, and the study also included long-term follow-up for those who continued on the once-daily medication.

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 Advagraf)
What this could lead to
If successful, this could show that a once-daily version of tacrolimus works as well as the twice-daily version in children, potentially simplifying their medication schedule.
What could go wrong
This is a small, early-phase study (Phase 2) with only 81 children. It focuses on drug levels, not long-term outcomes, and results may not apply to all transplant types or ages.

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

81 people

The number who actually took part.

Started

May 2011

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 16 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: * Must be able to swallow intact study medication capsules * Received a single solid organ transplant at least 6 months prior to entry into the study * The subject's parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable * Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months * Negative pregnancy test prior to enrolment (females) * Must agree to practice effective birth control during the study * Stable whole blood trough levels of tacrolimus in the range of 3.5 - 15ng/mL (+/-0.5ng/mL) and clinically stable in the opinion of the Investigator Exclusion Criteria: * Previously received a multiple organ transplant * Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months * Currently receiving Rapamycin, Certican or MPA (Myfortic®) * Chronic dysfunction of the allograft, in the opinion of the Investigator * Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study * The subject is pregnant or breast feeding

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As listed by the trial registrant

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

Heart transplantation Intestine transplantation Kidney transplantation Liver transplantation Lung transplantation

Contacts and locations

Locations

  • Site BE21

    Brussels, 1020, Belgium

  • Site BE22

    Brussels, 1200, Belgium

  • Site CZ42

    Prague, 150 06, Czechia

  • Site DE41

    Heidelberg, 69120, Germany

  • Site FR31

    Paris, 75743, France

  • Site FR32

    Paris, 75743, France

  • Site FR33

    Paris, 75908, France

  • Site FR34

    Bron, 69677, France

  • Site FR35

    Bron, 69677, France

  • Site GB61

    Manchester, M27 4HA, United Kingdom

  • Site GB62

    Birmingham, B4 6NH, United Kingdom

  • Site GB64

    London, WC1 3JH, United Kingdom

  • Site IT74

    Bergamo, 24127, Italy

  • Site IT75

    Palermo, 90127, Italy

  • Site PL51

    Warsaw, 04-730, Poland

  • Site PL52

    Warsaw, 04-730, Poland

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