AuthorisedTherapeutic use (Phase IV)Interventional

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation

This study is for children who have received a kidney transplant. Doctors want to find the best way to give them a very important medicine called tacrolimus. This medicine helps stop the body from rejecting the new kidney. The study is testing a special plan, like a guide, to help doctors work out the exact dose of tacrolimus needed. The goal is to give the medicine just once a day and make sure the amount in the child's blood is perfect. This helps the new kidney work well and keeps the child healthy. It's a way to make sure treatment is tailored to each child.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

28 Jun 2024

pediatric kidney transplant recipients

What is this study about?

This study is all about helping children who have had a kidney transplant get the best possible care. When a child receives a new kidney, their body naturally tries to fight it off, seeing it as something foreign. To prevent this, they need to take special medicines called immunosuppressants, and one of the most common and important is tacrolimus.

The challenge with tacrolimus is that everyone reacts to it a little differently. Too much can cause side effects, and too little might mean the new kidney isn't protected enough. This study is testing a smart way to figure out the right dose for each child. Think of it like a personalised recipe, using a special guide (called a dosing algorithm) to help doctors choose the perfect amount of medicine. Instead of taking the medicine multiple times a day, this study also looks at formulations that can be given just once a day, making it simpler for children and their families.

The main aim is to see if this personalised, once-a-day approach helps keep the level of tacrolimus in the child's blood within a specific, safe, and effective range shortly after their transplant. This is important because having the right level early on helps the new kidney settle in and reduces the risk of problems later. It's about making sure the medicine works as well as it can to protect the new kidney for years to come.

Key takeaways

This study aims for better, personalised tacrolimus dosing for children after kidney transplant.
It tests a special guide to help doctors find the right medicine amount.
Looking at once-a-day medicine options to make treatment easier.
The goal is to keep medicine levels steady for better kidney protection.
This is about improving standard care for children with new kidneys.

Who may be eligible?

This study is for children who have had a kidney transplant. There are no specific age limits; it's open to children from all age groups who have recently received a new kidney.

Both boys and girls are able to join this study, as long as they meet the other requirements. The main focus is on children who have just received their kidney transplant, as the study aims to see how well the new way of giving medicine works in the crucial days right after the operation.

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 your child recently had a kidney transplant?
Is your child currently taking tacrolimus medication?
Are you interested in a personalised approach to your child's medicine?
Are you happy for your child's treatment to follow a specific dosing guide?

Answer every question to see your result.

What does participation involve?

As a Phase IV study, this research carefully looks at how well different types of tacrolimus medicine work in everyday use after a kidney transplant. You would already be receiving treatment with tacrolimus, and the study would involve doctors using a special guide to help decide the best dose for your child. The different types of medicine being looked at include various forms of tacrolimus, such as capsules or granules, some of which are designed to be taken once a day.

You would have regular check-ups, as you would normally after a transplant, to monitor your child's health and the levels of tacrolimus in their blood. The study is interested in how stable these blood levels are, especially in the first few days after the transplant. The total duration of participation would align with the typical follow-up care your child receives after a kidney transplant.

Potential risks and benefits

Taking part in this study could mean your child receives a more tailored approach to their tacrolimus medication, potentially leading to more stable blood levels of the drug, which is good for their new kidney. It might also mean easier daily routines with once-a-day dosing options. However, as with any medical treatment, there are potential risks, such as side effects from the medication. Your child will be closely monitored, and you will always have the right to withdraw them from the study at any time without affecting their standard 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
Netherlands

Common questions

What is tacrolimus and why is it important?

Tacrolimus is a medicine that stops your child's body from rejecting their new kidney. It's very important for their long-term health after a transplant.

What does 'dosing algorithm' mean?

It's like a special guide or formula that helps doctors work out the best amount of medicine a child needs, making it more personalised.

What does 'once-daily formulation' refer to?

This means a version of the medicine that only needs to be taken once a day, which can be much easier than taking it multiple times.

Will my child receive extra medications?

No, this study looks at different ways to give the tacrolimus your child would already be taking after a kidney transplant, not new medicines.

What is a 'Phase IV' study?

This means the medicine is already approved, and the study is looking at the best ways to use it in real-world patients, like finding the best dose or schedule.