RecruitingOBSERVATIONAL

Avacostar - (PASS)

This study, called Avacostar, is for people in the UK and Germany who have ANCA-associated vasculitis (AAV), a rare but serious condition that causes inflammation of blood vessels. It's not a typical drug trial; instead, it observes what happens to people already being treated in their regular healthcare. Researchers will follow two groups: one receiving a newer medicine called avacopan, and another receiving standard treatments like cyclophosphamide or rituximab. The main goal is to understand any specific health issues that might occur in people taking avacopan. Patients will be followed for up to four years, with the study recruitment lasting about three years. It helps doctors learn more about how these treatments work in everyday life.

At a glance

Status

Recruiting

Sponsor

Vifor Fresenius Medical Care Renal Pharma

Enrolment target

500

Start

11 Sep 2023

Estimated completion

01 Dec 2030

ANCA-associated Vasculitis

What is this study about?

This study, called Avacostar, is looking at a serious condition called ANCA-associated vasculitis, or AAV. This condition causes your body's immune system to mistakenly attack your small blood vessels, leading to inflammation and damage. Doctors want to understand more about how different treatments work for AAV in real-world situations, outside of typical drug development trials.

This study will follow two groups of patients. One group will be receiving a newer medicine called avacopan, which has become an option for treating severe AAV. The second group will be receiving standard treatments that doctors have used for a while, such as cyclophosphamide or rituximab. It's important to remember that this isn't a study where you are assigned a new treatment; instead, it observes people who are already receiving these treatments as part of their regular care.

The main aim of this study is to keep a close eye on people taking avacopan to see if any particular health events happen. By comparing their experiences with those on standard treatments, doctors hope to gain a clearer picture of how avacopan works and its effects over time. The study will run for up to seven years, with patients being followed for up to four years after they join.

Key takeaways

This study observes real-world treatment of ANCA-associated vasculitis (AAV).
It compares people on avacopan with those on standard AAV treatments.
The main goal is to track specific health events in patients.
You won't receive new study medicine; you'll continue your prescribed treatment.
Participation involves sharing information from your regular doctor's visits.
The study helps doctors learn more about AAV treatments over time.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and have severe AAV, as diagnosed by your doctor. You should either already be taking avacopan or one of the standard treatments (cyclophosphamide or rituximab) for your AAV, or be about to start one of these treatments. If you've started one of these treatments in the last six months, you might still be able to join.

It's important that you understand what the study involves and agree to take part by giving your written consent. You also shouldn't be participating in another medical study that involves trying out a new treatment, unless your doctor and the study team have specifically discussed and agreed to it.

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?
Do you have severe ANCA-associated vasculitis (AAV)?
Are you currently taking or about to start avacopan, cyclophosphamide, or rituximab for your AAV?
Are you able to provide written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given new medicine for the study itself; you'll continue with the treatment your doctor has already prescribed for your AAV (either avacopan or a standard treatment). The study team will collect information about your health from your regular clinic visits. They might also look back at some of your medical records from up to six months before you joined. You will continue to have periodic check-ups with your doctor as you normally would for your condition, and the study team will gather information from these visits.

You will be followed for up to four years from when you join the study. There are no extra hospital visits or tests specifically for this study beyond what your doctor would normally recommend for your care. The overall study will run for up to seven years, including a period of about three years when new participants are joining.

Potential risks and benefits

The main benefit of participating is that you'll be contributing valuable information that helps doctors better understand AAV and how treatments like avacopan work in real-world settings. This knowledge can ultimately help improve care for future patients. Since this study doesn't involve new treatments or procedures beyond your normal care, the direct risks are generally low. However, all medical treatments have potential side effects, and your doctor will discuss these with you as part of your usual care. You are free to withdraw from the study at any time without affecting your medical care.

Locations (35)

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

Charité University Medicine
Verified postcode
Berlin, Germany· Recruiting
University Hospital of Cologne
Verified postcode
Cologne, Germany· Recruiting
Municipal Hospital Dresden
Verified postcode
Dresden, Germany· Not yet recruiting
University Hospital Essen
Verified postcode
Essen, Germany· Recruiting
University Hospital Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
University Medical Center Göttingen
Verified postcode
Göttingen, Germany· Recruiting
University Hospital Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
KRH Klinikum Siloah
Verified postcode
Hanover, Germany· Recruiting
Rheumazentrum Ruhrgebiet
Verified postcode
Herne, Germany· Recruiting
LMU
Verified postcode
Munich, Germany· Not yet recruiting
Medius Kliniken
Verified postcode
Plochingen, Germany· Recruiting
St. Josef-Stift Sendenhorst
Verified postcode
Sendenhorst, Germany· Not yet recruiting

Common questions

What is ANCA-associated vasculitis (AAV)?

AAV is a serious condition where your immune system attacks your small blood vessels, causing inflammation.

Will I receive new medicine in this study?

No, you will continue with the AAV treatment (avacopan or standard care) your doctor has already prescribed for you.

How long will I be involved in the study?

You'll be followed for up to four years as part of your regular clinic visits.

Are there extra appointments for the study?

No, data will be collected from your existing, routine clinic visits for your AAV.

Why is this study being done?

It helps doctors learn more about how AAV treatments work in everyday life and to identify any specific health events.

How to find out more

Avacostar Study Team

clinicaltrials@cslbehring.com +41 58 851 80 00 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.