Active not recruitingOBSERVATIONAL

Subclinical Cytomegalovirus Reactivation in Acute ANCA-associated Vasculitis

This study is exploring how a common and usually harmless virus, Cytomegalovirus (CMV), might affect people with a serious immune condition called ANCA-associated vasculitis (AAV). We're particularly interested in patients who are newly diagnosed or experiencing a flare-up. Researchers want to understand how often CMV reactivates in these patients and if it leads to worse health outcomes, like kidney damage or a poorer response to treatment. The study also aims to see if CMV reactivation affects certain immune cells called monocytes and whether these cells play a role in kidney problems. Ultimately, the goal is to see if preventing CMV reactivation could help AAV patients feel better and have better long-term health.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Birmingham NHS Foundation Trust

Enrolment target

Start

19 Apr 2022

Estimated completion

22 Dec 2025

ANCA Associated Vasculitis

What is this study about?

This study aims to understand the connection between a very common virus called Cytomegalovirus (CMV) and a serious illness known as ANCA-associated vasculitis (AAV). AAV is a condition where your body's immune system mistakenly attacks its own small and medium-sized blood vessels, causing inflammation and damage to organs like the kidneys. To treat AAV, doctors often use strong medicines that calm down the immune system. We know that these medicines can sometimes make people more vulnerable to infections, or allow viruses they already carry, like CMV, to 'wake up' or reactivate.

CMV is a type of herpes virus. Many people carry CMV throughout their lives without ever knowing it, and it usually doesn't cause problems in healthy individuals. However, when someone's immune system is weakened, CMV can become active again. While obvious CMV disease is rare in AAV patients, previous research suggests that CMV reactivation might be happening 'under the radar' (asymptomatically) and could be linked to worse health problems for people with AAV, such as kidney issues, more infections, or even a higher risk of heart problems and strokes. This study wants to find out just how often this 'silent' CMV reactivation happens in newly diagnosed AAV patients or those having a flare-up, and whether it's truly connected to these worse outcomes.

The researchers also have a special interest in how CMV might affect the kidneys. They believe that if CMV reactivates, it might cause certain immune cells, called monocytes, to behave differently. These altered monocytes could then contribute to ongoing kidney damage in AAV patients. By carefully observing patients over a year, collecting blood and urine samples, and looking at kidney tissue, the study hopes to uncover these links. If CMV reactivation is indeed common and harmful, it could open the door to future studies exploring new treatments to prevent CMV reactivation and ultimately improve the lives of people living with AAV.

Key takeaways

This study explores how CMV affects people with ANCA-associated vasculitis (AAV).
It focuses on newly diagnosed AAV patients or those having a flare-up.
Researchers want to see if CMV reactivation leads to worse outcomes, especially kidney damage.
Participation involves about 10 visits over a year, mainly for blood and urine samples.
The study won't change your current AAV treatment.
Findings could lead to new ways to improve care for AAV patients.

Who may be eligible?

To be considered for this study, you would need to be under the care of Queen Elizabeth Hospital. You must also have received a new diagnosis of ANCA-associated vasculitis (AAV) within the last two weeks, or have experienced a significant flare-up of your AAV that requires specific treatment to bring it under control. It's also important that you are over 18 years old and willing to participate and attend all the study visits.

Crucially, you would have to have been previously infected with CMV. The study team will check for this. It's also important that you are able to understand and agree to take part, and that you can attend the scheduled appointments.

You wouldn't be able to join if doctors suspect you have a different illness instead of AAV, or if you're unable to give your consent to participate, perhaps due to health issues that affect your ability to make decisions. If you know you wouldn't be able to come to the study appointments, then this study wouldn't be right for you.

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 a patient at Queen Elizabeth Hospital?
Have you been newly diagnosed with AAV or had a major AAV flare-up in the last two weeks?
Are you aged 18 or over?
Have you previously had CMV (the study team will check for this)?
Are you able to attend about 10 study visits over a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be followed for a full year. During this time, you would have about 10 study visits. Whenever possible, these visits will be scheduled at the same time as your regular appointments at the vasculitis clinic, to make it easier for you. At each of these visits, you'll be asked to provide blood and urine samples. You'll also be asked questions about your vasculitis and how you're feeling. The study team may also look at kidney tissue samples that were collected if you had a kidney biopsy when you were first diagnosed.

Potential risks and benefits

Participating in this study might help researchers better understand ANCA-associated vasculitis and how a common virus could affect it, potentially leading to improved care for patients in the future. The main risks involve the discomfort of giving blood samples at multiple visits, which can sometimes cause bruising or slight pain. There are no direct medical treatments given as part of this study, so it won't change your usual AAV care. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

University Hospitals Birmingham
Verified postcode
Birmingham, United Kingdom

Common questions

What is CMV and why are you studying it?

CMV (Cytomegalovirus) is a common virus that many people carry. We're studying it because we think it might reactivate 'silently' in people with ANCA-associated vasculitis and possibly make their condition worse, even if they don't feel sick from the virus itself.

What is 'ANCA-associated vasculitis'?

It's a serious condition where your body's immune system mistakenly attacks and inflames your blood vessels. This can damage organs like the kidneys. It's often treated with strong medicines.

Will this study change my vasculitis treatment?

No, this is an observational study, which means we are only watching and collecting information. It will not involve any new medications or changes to your current vasculitis treatment.

How often will I need to visit the hospital?

You'll have about 10 study visits over 12 months. We'll try to book them at the same time as your regular clinic appointments to make it easier for you.

What happens to the blood and urine samples?

The samples will be used to look for signs of CMV reactivation and to measure how your body is responding to your vasculitis and treatment.