AuthorisedTherapeutic confirmatory (Phase III)Interventional

Effectiveness of a preventive strategy for cytomegalovirus infection guided differently from a universal prophylactic strategy in kidney transplant patients - CYTOPREV

This research, called CYTOPREV, is looking into the best ways to stop a common infection called cytomegalovirus (CMV) in people who have had a kidney transplant. CMV can cause serious problems for transplant patients, so preventing it is very important. The study is comparing a standard preventative treatment with a new approach using a medicine called VALGANCICLOVIR VIATRIS. Researchers want to see if this new strategy is more effective at stopping CMV infections within six months of the transplant. They will also look at how many patients need treatment for CMV, whether the infection causes actual disease, and examine the cost-effectiveness of this new prevention method. It's a key step in finding better care for kidney transplant patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

144

Start

13 Aug 2024

CMV

What is this study about?

When you have a kidney transplant, your immune system is often weakened to stop your body from rejecting the new kidney. This makes you more vulnerable to certain infections, including one called cytomegalovirus, or CMV. While CMV might not cause problems in healthy people, it can be quite serious for transplant patients, sometimes leading to illness or even affecting the transplanted kidney.

This study, called CYTOPREV, aims to find the best way to prevent CMV infection in kidney transplant patients. Currently, there are ways to prevent CMV, but doctors are always looking for even better and more effective methods. This research is comparing a standard preventive approach with a different strategy that uses a specific medicine called VALGANCICLOVIR VIATRIS. The main goal is to see if this new approach can significantly reduce the number of patients who get CMV infection within six months after their transplant.

By taking part, you would be helping doctors and researchers understand if this different prevention strategy is more effective, safer, and potentially more cost-efficient than what is currently used. This information is really important because it could lead to improved care and better health outcomes for future kidney transplant patients and their families.

Key takeaways

This study evaluates prevention strategies for CMV infection in kidney transplant patients.
It compares a new approach using VALGANCICLOVIR VIATRIS with standard prevention.
The goal is to reduce CMV infections within six months post-transplant.
It's a Phase III study, meaning it's a key step in confirming effectiveness.
Participation helps improve care for future kidney transplant recipients.
Adults aged 18 and over can participate, regardless of gender.

Who may be eligible?

This study is looking for adult kidney transplant patients to take part. To be eligible, you must be at least 18 years old – there's no upper age limit, so older adults can also participate.

Participants can be male or female. The doctors will check other specific medical details to make sure the study is right for you, and that you meet all the necessary health requirements.

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 at least 18 years old?
Have you recently had, or are you about to have, a kidney transplant?
Are you able to take oral medication regularly?
Are you able to attend regular follow-up appointments and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. Once enrolled, you would receive either the VALGANCICLOVIR VIATRIS medicine or the standard preventive treatment, depending on which group you are assigned to. This would be a tablet you take by mouth.

Over the course of the study, which lasts for about a year after your transplant, you would attend regular visits and have various assessments. These might include blood tests to check for CMV infection and to monitor your overall health, as well as discussions with the study team about how you're feeling. The study focuses on monitoring your health for six months, and then up to a year, after your kidney transplant.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving close medical attention and contributing to new knowledge about CMV prevention, which could help future patients. However, there are also potential risks, including side effects from the medication or the discomfort of blood tests. The medical team will explain all known side effects. 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.

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Unverified
France

Common questions

What is CMV?

CMV, or cytomegalovirus, is a common virus. For most healthy people, it causes no symptoms or mild illness, but it can be serious for people with weakened immune systems, like those who have had an organ transplant.

Why is this study important for kidney transplant patients?

CMV infection can cause serious problems after a kidney transplant. This study helps doctors find better ways to prevent these infections, which can improve the health and recovery of patients.

What is VALGANCICLOVIR VIATRIS?

It's a medicine that helps prevent or treat viral infections like CMV. This study is testing how effective it is as a preventive strategy after a kidney transplant.

Will I know if I'm getting the new treatment or the standard one?

Studies like this often 'blind' participants, meaning you might not know which treatment you are receiving. This helps make the study results more reliable. The study team will explain how this works.

How long will I be in the study?

The main part of the study involves monitoring you for about six months after your transplant, with follow-up to one year, to see how well the prevention strategy works.