A multi-center interventional study to assess pharmacokinetics, effectiveness and tolerability of prolonged-release Tacrolimus after Paediatric Kidney Transplantation (Pro-Tac)
This research study, called Pro-Tac, is for children in the UK who have received a kidney transplant. The main goal is to carefully compare two different forms of a medicine called tacrolimus: Envarsus and Prograf. Tacrolimus is very important for kidney transplant patients because it helps prevent their body from rejecting the new kidney. The study will look at how the body uses and processes each medicine, how effective they are in preventing rejection, and if they cause any side effects (this is called tolerability). By comparing these two versions, doctors hope to understand which one might be better or more suitable for children after a kidney transplant. It’s about making sure these children get the best possible care.
At a glance
What is this study about?
This study, known as Pro-Tac, is investigating a very important medicine called tacrolimus. This medicine is given to children who have had a kidney transplant to help stop their body from rejecting the new kidney. When someone receives an organ transplant, their immune system might see the new organ as 'foreign' and try to attack it. Tacrolimus helps by calming down the immune system so it doesn't harm the new kidney.
The study is specifically looking at two different forms of tacrolimus: Envarsus and Prograf. Both are designed to release the medicine slowly over time. Researchers want to compare them closely to understand a few key things:
1. **How the body handles the medicine:** They'll study how each medicine is absorbed, how it travels through the body, and how long it stays active. This helps doctors know the right dose to give for the best effect. 2. **How well they work:** They want to see if both medicines are equally good at preventing the body from rejecting the new kidney. 3. **Side effects and comfort:** They'll also check if one medicine causes more side effects or if children tolerate one better than the other.
By carefully comparing Envarsus and Prograf, doctors hope to gather important information that can help them decide which form of tacrolimus is most effective and safest for children who have received a new kidney. The ultimate goal is to improve the health and well-being of these young patients.
Key takeaways
- This study compares two kidney transplant medicines, Envarsus and Prograf.
- It aims to understand how each medicine works in children.
- It checks for effectiveness and potential side effects.
- Participation involves regular hospital visits for blood tests.
- Caucasian children who have had a kidney transplant may be eligible.
Who may be eligible?
This study is looking for children who have had a kidney transplant and are of Caucasian ethnicity. Both boys and girls can take part.
There isn't a specific age limit mentioned, so it's best to discuss with the study team if your child falls within the general age range for children receiving a kidney transplant.
If you think your child meets these general criteria, the study team will then carry out more detailed checks to make sure the study is a good fit for them. This is to ensure their safety and that the research will be helpful.
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 had a kidney transplant?
- Is your child of Caucasian background?
- Is your child currently taking or considering taking tacrolimus?
- Are you able to attend regular hospital visits for your child?
What does participation involve?
If your child takes part, they would receive either the Envarsus or Prograf form of tacrolimus, prescribed by the study doctors. These are both prolonged-release tablets. The study would involve several visits to the hospital or clinic at set times to have blood tests. These blood tests help doctors understand how the medicine is working in your child’s body and how much is there. They will also check for any side effects and monitor your child’s general health closely.
Regular check-ups and monitoring would continue throughout the study period. The total duration of participation isn't specified in detail here, but these types of studies typically involve participation over several months to ensure thorough assessment of the medication.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is tacrolimus and why is it important?
Tacrolimus is a medicine given to children after a kidney transplant to stop their body from rejecting the new kidney. It works by calming down the immune system.
What's the difference between Envarsus and Prograf?
They are both forms of tacrolimus. This study is comparing them to see if they work similarly and if one is better tolerated or processed by the body.
Will my child definitely get special treatment?
Your child will receive very close monitoring of their medication and health during the study, which is a high level of care.
What kind of tests will be done?
Your child will have regular blood tests to check how the medicine is working and to monitor their general health.
Can we stop participating if we change our mind?
Yes, you can withdraw your child from the study at any time, and their medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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