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

NCT ID NCT01294020

Completed Disease control Sponsor: Astellas Pharma Europe Ltd. Source: ClinicalTrials.gov ↗

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

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