AuthorisedTherapeutic confirmatory (Phase III)Interventional

REVOLUTION; Randomized controlled trial comparing immediate versus extended release tacrolimus; reducing calcineurin inhibitor related toxicity in lung transplantation patients

This research study is for people who have recently had a lung transplant. It's looking at a commonly used medicine called tacrolimus, which helps prevent your body from rejecting the new lung. We're comparing two different forms of this medicine: a standard capsule (Prograf) and a newer, longer-acting tablet (Envarsus). The main goal is to find out if one of these forms causes fewer side effects, particularly problems with kidney function. By finding a better way to give this important medicine, we hope to improve the long-term health and well-being of lung transplant patients. This is a Phase III study, which means it's a key step to confirm how effective and safe these treatments are.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

140

Start

28 Jan 2025

lung transplantation

What is this study about?

When you have a lung transplant, your body’s immune system might see the new lung as foreign and try to attack it. This is called rejection. To stop this from happening, doctors give you special medicines, and one of the most common is called tacrolimus. This medicine helps to quiet down your immune system so your body accepts the new lung.

However, like many powerful medicines, tacrolimus can sometimes have side effects. A common concern with tacrolimus is that it can affect kidney function. This study, called REVOLUTION, wants to find out if there's a better way to give you this important medicine that might cause fewer problems for your kidneys.

We're comparing two ways to take tacrolimus: one is a standard capsule that releases the medicine quickly, and the other is a special tablet that releases the medicine slowly over a longer time. By comparing these two, we hope to learn if the longer-acting tablet can be just as good at preventing rejection but with less risk to your kidneys, ultimately helping you stay healthier for longer after your transplant.

Key takeaways

This study compares two ways of taking tacrolimus after a lung transplant.
The main goal is to reduce kidney side effects often linked to tacrolimus.
It's for adults who have recently had a lung transplant.
Participation involves taking one of two forms of tacrolimus and regular health checks.
The study aims to improve long-term health for lung transplant patients.

Who may be eligible?

This study is looking for people who have recently had a lung transplant. You need to be at least 18 years old to take part, and there’s no upper age limit. Both men and women are welcome to participate.

To be considered for this study, you would typically be an adult who has just received a new lung and is starting on tacrolimus medicine. The study doctors will carefully check your health information to make sure it's safe and appropriate for you to join.

Quick self-check

I am at least 18 years old.
I have recently had a lung transplant.
I am currently, or will be, taking tacrolimus medicine.
I am willing to have regular health checks and blood tests.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the standard tacrolimus capsule or the longer-acting tacrolimus tablet. This is like flipping a coin, so neither you nor your doctor can choose which one you get. You would then take this medicine as prescribed.

Taking part would involve regular visits to the hospital or clinic. These appointments would be similar to your usual follow-up care after a lung transplant, but with additional tests. These tests would include blood tests to check your tacrolimus levels and kidney function, and other assessments to monitor your overall health. The study will follow you over a period to see how you respond to the medicine. The total duration would be explained by the study team.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping doctors find the best way to give tacrolimus, which might reduce side effects like kidney problems in the future. However, there are also potential risks involved, such as side effects from the medication itself, which will be carefully monitored. You will receive very close medical attention throughout the study. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is tacrolimus?

Tacrolimus is a medicine used to stop your body from rejecting a new organ, like a transplanted lung, by calming down your immune system.

Why is kidney function important in this study?

Sometimes, tacrolimus can make kidney problems worse. This study wants to see if one form of the medicine is gentler on your kidneys.

What is the difference between a capsule and a prolonged-release tablet?

A capsule often releases medicine quickly, while a prolonged-release tablet lets the medicine out slowly over a longer period.

Will I know which medicine I'm taking?

In this type of study, you wouldn't know which form of tacrolimus you're taking, as it helps make the results fair and unbiased.

Who is funding this research?

Details about funding would be provided by the research team if you are interested in joining the study.