Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow Up

This study is for children who have had an organ transplant, such as a new liver, kidney, heart, lung, or bowel. They are currently taking a medicine called tacrolimus (Prograf) to stop their body from rejecting the new organ. This research aims to see if switching to a different, longer-acting version of the same medicine, called Advagraf, is safe and effective. Researchers will compare how the body uses both medicines and will carefully watch for any side effects and how well the new organ is working over time. The goal is to find out if Advagraf could be a good long-term treatment option for these children.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Astellas Pharma Europe Limited

Enrolment target

Start

28 Jun 2024

Prophylaxis of primary liver kidney heart lung and intestinal organ transplant rejection

What is this study about?

When someone has an organ transplant, their immune system, which usually fights off germs, can sometimes see the new organ as a foreign invader and try to attack it. This is called 'rejection'. To stop this from happening, patients need to take special medicines, called immunosuppressants, for the rest of their lives. One of these important medicines is tacrolimus.

There are different versions of tacrolimus. Children participating in this study are already taking a version called Prograf. This study wants to find out if switching to another version called Advagraf, which is designed to be released slowly into the body, is a good idea. The main aim is to understand how the body uses Advagraf compared to Prograf, making sure the right amount of medicine is in the body to protect the new organ. This kind of research helps doctors understand if new medicines are as safe and effective as existing ones.

Researchers will be looking closely at things like how much medicine is in the blood, how quickly it gets there, and how long it stays. They will also keep a close eye on the general health of the children, including any side effects, and if the new organ continues to work well. This study will follow the children for a long time to understand the lasting effects of switching medicines.

Key takeaways

This study evaluates a new, longer-acting transplant rejection medicine (Advagraf) for children.
Children already taking Prograf for a stable transplant are eligible.
It compares how the body uses Advagraf versus Prograf.
Close monitoring of medicine levels and overall health is a key part of the study.
The study aims to improve long-term care for children with organ transplants.

Who may be eligible?

This study is specifically for children who have already had an organ transplant, such as a liver, kidney, heart, lung, or bowel transplant. They must be in a stable condition, meaning their new organ is working well and their health is generally good at the time of joining the study. They should already be taking a medicine called Prograf to prevent rejection.

There are no specific age limits mentioned, meaning children of any age who meet the other requirements could potentially take part. Both boys and girls are welcome to participate. The study is about comparing how two versions of the same medicine work in real-life situations where children are already stable after their transplant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Has my child had an organ transplant (liver, kidney, heart, lung, or bowel)?
Is my child currently taking Prograf to prevent transplant rejection?
Is my child's health generally stable since their transplant?
Do I understand that this study involves switching medicines under supervision?

Answer every question to see your result.

What does participation involve?

Taking part would involve regular visits to a hospital or clinic. During these visits, the medical team would collect blood samples to measure the levels of the medicine in your child's body. They would also monitor your child's general health, measure vital signs like heart rate and blood pressure, and conduct standard laboratory tests. Your child would switch from their current tacrolimus medicine (Prograf) to the new longer-acting version (Advagraf). The medical team would carefully manage this switch and adjust the dose as needed.

Throughout the study, you would also be asked about any side effects your child might experience. The study involves a long-term follow-up to see how your child's health and the transplanted organ fare over an extended period after switching medicines. The exact number and frequency of visits, as well as the total duration of the study, would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part could include closer monitoring of your child's health and organ function by a team of specialists. If Advagraf proves to be a good option, it might offer advantages such as fewer daily doses or a more stable level of medicine in the body. Potential risks are similar to those of any medicine, including side effects, and the possibility that the new medicine might not work as well for every individual, although close monitoring aims to catch issues quickly. You have the right to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is tacrolimus and why is it important?

Tacrolimus is a medicine that stops your body from rejecting a new organ after a transplant. It helps your immune system accept the new organ.

What's the difference between Prograf and Advagraf?

They are both tacrolimus, but Advagraf is a longer-acting version, meaning it's designed to be taken less often, possibly once a day, compared to Prograf.

Will my child's current medicine be stopped immediately?

No, your child would switch from Prograf to Advagraf under careful medical supervision. The team will guide the transition smoothly.

How long will my child be followed in this study?

This study includes a 'long-term follow-up,' meaning your child's health and organ will be monitored for an extended period after switching medicines.

What kind of tests will my child have?

They will have regular blood tests to check medicine levels, general health checks, and assessments to ensure the transplanted organ is working well.