AuthorisedTherapeutic use (Phase IV)Interventional

Safety and efficacy of steering of immunosuppression based on BKPyV-specific T cells in case of BK Polyomavirus (BKPyV) DNAe- mia after kidney transplantation

This study is investigating a new way to manage specific medications for people who have received a kidney transplant and are dealing with a viral infection called BK Polyomavirus (BKPyV). This virus can sometimes cause problems after a transplant. The research aims to see if adjusting these medicines based on how your body's immune system is responding to the virus can help get rid of the BKPyV infection more effectively. Researchers will be looking at how quickly the virus levels in your blood go down. They will also check on the health of your new kidney, look for any signs of the body rejecting the new organ, and monitor the overall levels of your anti-rejection medications. The main goal is to find a safer and more effective way to balance keeping the virus under control while also protecting your transplanted kidney.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Paediatrisches Forschungsnetzwerk gGmbH, PROFIL Institut fuer Stoffwechselforschung GmbH

Enrolment target

300

Start

17 Apr 2025

BK Polyomavirus DNAemia after kidney transplantation

What is this study about?

When you have a kidney transplant, you need to take special medicines called immunosuppressants. These medicines stop your body from rejecting the new kidney. However, they can also make it harder for your body to fight off common infections. One such infection is caused by a virus called BK Polyomavirus (BKPyV), which can become active when your immune system is weakened. If BKPyV isn't controlled, it can sometimes harm the transplanted kidney.

This study is looking at a new way to adjust your anti-rejection medicines if you get a BKPyV infection after your kidney transplant. Instead of a standard approach, doctors will be checking specific cells in your blood that fight off the BKPyV virus. By understanding how well your immune system is responding, they hope to adjust your medications more precisely. This could mean they might be able to lower some medicines if your body is fighting the virus well, or adjust them in other ways to help clear the infection while still protecting your new kidney.

The main purpose of this research is to see if this new, more personalised approach to adjusting anti-rejection medicines can help get rid of the BKPyV infection faster and more effectively. The study will also carefully monitor the health of your transplanted kidney and check for any other issues that might arise. This information will help doctors in the future decide on the best way to care for kidney transplant patients who develop BKPyV infection.

Key takeaways

This study is for kidney transplant patients with active BK Polyomavirus infection.
It aims to find better ways to adjust anti-rejection medicines to fight the virus.
Researchers will monitor virus levels and kidney health closely.
The goal is to clear the infection safely while protecting the transplanted kidney.
This is a 'Phase IV' study, meaning the medicines are already approved and being studied for new ways to use them.

Who may be eligible?

To be part of this study, you would need to be an adult, 18 years old or older. Both men and women are welcome to take part.

You must have recently had a kidney transplant and have been diagnosed with BK Polyomavirus (BKPyV) DNAemia. This means the BKPyV virus has been detected in your blood after your transplant.

Detailed criteria for things like your overall health, other medical conditions, and medicines you are taking would be carefully reviewed by the study doctors to make sure the study is a good fit for you and safe for your health.

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 18 years old or older?
Have you recently had a kidney transplant?
Have doctors told you that you have BK Polyomavirus (BKPyV) in your blood?
Are you currently taking anti-rejection medicines for your kidney transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be monitored closely. This would involve regular blood tests to check your BK Polyomavirus levels and the health of your kidney. Your existing anti-rejection medicines, such as Tacrolimus or Sirolimus, would be carefully reviewed and potentially adjusted by your doctor based on your body's response to the virus. You would also have tests to look at specific immune cells that fight BKPyV.

The study will follow your progress over several months. You would continue to attend your usual clinic appointments, and the study team might add extra visits or tests to get all the necessary information. The exact number of visits and tests would be explained in full by the study team. Your commitment would be for the duration of the study period, which tracks how long it takes for your BKPyV infection to clear or significantly reduce.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more personalised and potentially more effective way to manage your BK Polyomavirus infection after your kidney transplant. Researchers will be closely monitoring your health, which means you will receive a high level of medical attention. However, like all medical studies, there are potential risks. Adjusting anti-rejection medications can sometimes lead to side effects or, in rare cases, affect the donated kidney. You will be closely monitored for any such issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Germany

Common questions

What is BK Polyomavirus (BKPyV)?

BKPyV is a common virus that most people carry without knowing it. After a kidney transplant, when you take anti-rejection medicines, the virus can become active and sometimes cause problems for the new kidney.

Why is this study important for kidney transplant patients?

It's important because it aims to find a better way to balance treating the BKPyV infection with protecting your new kidney. Currently, managing this can be tricky, and this study hopes to make it safer and more effective.

Will my anti-rejection medicines be stopped?

No, your anti-rejection medicines will not be stopped. The study is looking at *adjusting* them, not stopping them, to help fight the virus while still preventing rejection of your new kidney.

What does 'DNAemia' mean?

DNAemia simply means that the virus's genetic material (DNA) has been found in your blood. It's how doctors detect the active BKPyV infection.

How long will I be in the study?

The study will track how long it takes for your BKPyV infection to successfully clear or significantly reduce. This timeframe can vary for each person, but you will be closely monitored for a period of several months.