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RecruitingPHASE3INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE3
Sponsor
Bristol-Myers Squibb
Enrolment target
102
Start
21 Jul 2021
Estimated completion
30 Jun 2034

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.

  1. Are you between 12 and 17 years old?
  2. Have you had a kidney transplant over 6 months ago?
  3. Are you currently taking certain anti-rejection medicines and is your kidney generally stable?
  4. Have you had the Epstein-Barr virus (EBV) in the past, but not an active infection now?
  5. Have you completed your initial COVID-19 vaccination course?
  6. Have you recently had serious kidney rejection or previously taken belatacept?
Answer every question to see your result.

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

Participating in this study might offer the benefit of trying a different anti-rejection medicine that could potentially lead to better long-term kidney health or fewer side effects than your current treatment, though this is not guaranteed. However, there are also potential risks involved, such as side effects from the new medication or complications with your kidney. The study team will explain all the known risks associated with both treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (38)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0042
    Verified postcode
    Birmingham, United States· Withdrawn
  • Local Institution - 0041
    Verified postcode
    Los Angeles, United States· Withdrawn
  • Local Institution - 0014
    Verified postcode
    Washington D.C., United States· Withdrawn
  • Local Institution - 0022
    Verified postcode
    Hollywood, United States· Withdrawn
  • Local Institution - 0045
    Verified postcode
    Miami, United States· Withdrawn
  • Local Institution - 0049
    Verified postcode
    Atlanta, United States· Withdrawn
  • Local Institution - 0033
    Verified postcode
    Chicago, United States· Withdrawn
  • Local Institution - 0017
    Verified postcode
    Baltimore, United States· Withdrawn
  • Local Institution - 0044
    Verified postcode
    Boston, United States· Withdrawn
  • Local Institution - 0043
    Verified postcode
    St Louis, United States· Withdrawn
  • Local Institution - 0024
    Verified postcode
    Durham, United States· Withdrawn
  • Local Institution - 0025
    Verified postcode
    Cincinnati, United States· Withdrawn

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?

Register your interest

Share your details and the research team for "A Study to Evaluate the Benefits and Risks of Conversion of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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