A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
This research study is for teenagers aged 12 to 17 who have had a kidney transplant. Doctors want to compare two different types of medicine used to stop the body from rejecting the new kidney. One type is called a calcineurin inhibitor, which many patients are already taking. The other is a belatacept-based treatment. The study will look at the good points and possible downsides of switching patients to the belatacept medicine compared to staying on their current treatment. Researchers will also carefully monitor how well young people take their medicines as prescribed. This helps understand which treatment plan is safer and more effective for long-term kidney health in teenagers.
At a glance
What is this study about?
This study is about young people, aged 12 to 17, who have received a kidney transplant. After a kidney transplant, patients need to take special medicines called immunosuppressants. These medicines help prevent the body's immune system from attacking and rejecting the new kidney. There are different types of these medicines, and doctors are always trying to find the best and safest options.
Currently, many young transplant patients take a type of medicine called a calcineurin inhibitor. This study is looking at whether switching to a different type of medicine, called a belatacept-based treatment, might be better for some young people. Researchers will compare those who switch to belatacept with those who continue taking their current calcineurin inhibitor medicine. They want to understand the benefits and any potential risks of each approach, as well as how consistently patients take their medicines.
The main goal is to find out if the belatacept-based treatment offers advantages for young kidney transplant recipients, such as better long-term kidney health or fewer side effects, compared to the standard treatment. This information will help doctors make better decisions about which medicines are most suitable for teenagers after a kidney transplant.
Key takeaways
- This study is for young people aged 12-17 with a kidney transplant.
- It compares two different types of anti-rejection medicines.
- The goal is to find out if a newer medicine (belatacept) is better than the current standard treatment.
- Participation involves regular check-ups and monitoring of your health and medicines.
- You can discuss this study with your doctor to see if it's right for you.
Who may be eligible?
This study is looking for young people aged between 12 and 17 years old who have had a kidney transplant. You must have received your new kidney at least six months ago from either a living or deceased donor. You also need to be taking a stable dose of certain anti-rejection medicines (like tacrolimus or cyclosporine, along with mycophenolate) and have generally stable kidney function for at least three months.
There are also some important health checks you'll need to pass. For example, you must have shown signs of having had the Epstein-Barr virus (EBV) in the past, but not have an active infection of it now. You also need to have completed your first course of COVID-19 vaccinations at least six weeks before joining the study.
You would not be able to join if you have never had EBV or if your EBV status isn't known. You also can't join if you've had a recent serious rejection episode of your kidney (in the last six months) or if you've had certain types of strong rejection in the past. If you've previously taken belatacept or been in another belatacept study with your current kidney, you also wouldn't be eligible. There are also a few other medical reasons that might mean you can't take part.
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.
- Are you between 12 and 17 years old?
- Have you had a kidney transplant over 6 months ago?
- Are you currently taking certain anti-rejection medicines and is your kidney generally stable?
- Have you had the Epstein-Barr virus (EBV) in the past, but not an active infection now?
- Have you completed your initial COVID-19 vaccination course?
- Have you recently had serious kidney rejection or previously taken belatacept?
What does participation involve?
If you join this study, the doctors and nurses will monitor your health very carefully. Some participants will switch from their current anti-rejection medicine to a new belatacept-based treatment, while others will continue with their current medicine. You will need to attend regular clinic visits for check-ups, blood tests, and to discuss how you're feeling and how well you're taking your medication. The doctors will also look at how your kidney is working over time. The exact number of visits and the total length of time you'll be involved in the study will be explained in more detail by the study team, but it will involve ongoing assessments as part of your transplant care.
Potential risks and benefits
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Common questions
What are immunosuppressive medications?
These are medicines that weaken your body's immune system to stop it from attacking and rejecting your new kidney.
What is the difference between belatacept and calcineurin inhibitors?
They are both types of anti-rejection medicines but work in slightly different ways. This study is comparing them to see which is best for teenagers.
Will I have to take new medicines?
Some participants will switch from their current medicine to a belatacept-based treatment, and some will continue their current treatment. You will be told which group you are in.
How long does the study last?
The exact duration for each participant varies and will be explained by the study team, but it involves ongoing monitoring of your kidney health and medicines.
What happens if I change my mind?
You can decide to leave the study at any point, and this won't affect your regular medical care from your doctors.
How to find out more
BMS Study Connect Contact Center www.BMSStudyConnect.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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