A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease
Antibody-mediated kidney diseases, such as membranous nephropathy, happen when the body's immune system mistakenly attacks healthy filters in the kidneys. This damage causes protein to spill into the urine and can slowly reduce how well the kidneys work. This Phase 2 clinical trial is testing an experimental drug called surovatamig (also known as AZD0486) in adults with this condition. Researchers want to find out if the drug is safe, how the body processes it, and whether it successfully lowers protein levels in the urine after six months. Participants will be monitored closely for up to two years to see if the medicine helps put the kidney disease into remission and prevents relapses. Because this is an open-label trial, all participants receive the study medicine without any dummy drug (placebo). Taking part is completely voluntary.
At a glance
What is this study about?
Our kidneys have millions of tiny filters that clean waste from the blood while keeping vital proteins inside the body. In antibody-mediated kidney diseases, such as primary membranous nephropathy, the immune system becomes confused. It produces harmful proteins called antibodies that attack the kidney filters. This causes inflammation and lets protein leak into the urine, which can lead to long-term kidney damage over time.
Surovatamig is an experimental drug designed to stop this harmful attack. It works by targeting the specific immune cells (called B-cells) that produce these kidney-damaging antibodies. By reducing these cells, doctors hope to calm down the inflammation, stop protein leaking into the urine, and give the kidneys a chance to heal.
This trial is a Phase 2 study. That means researchers are testing the drug in a focused group of patients to check both its safety and how effectively it works. Because it is an open-label study, every person who joins will receive the active study medicine; there is no placebo.
Finding new ways to treat immune-related kidney disease is very important. Current treatments often involve strong medicines that suppress the whole immune system and can cause unpleasant side effects. If surovatamig proves successful, it could offer a more targeted and effective way to protect kidney health.
Key takeaways
- Tests a new medicine called surovatamig for antibody-mediated kidney disease.
- Aims to lower protein leakage in the urine and protect kidney health.
- Open to adults aged 18 and older with eligible kidney conditions.
- All participants receive the active study treatment (no placebo).
- Requires regular clinic visits, blood tests, and urine checks for up to two years.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with an antibody-mediated kidney condition, such as primary membranous nephropathy. Doctors will check whether you have active signs of the condition, such as raised protein levels in your urine or specific antibodies in your blood.
Men and women can both take part. However, you may not be able to join if your kidneys are already severely damaged or failing, if you have an active, serious infection, or if you are receiving other treatments that could interfere with the study drug.
The study team will run detailed health checks, including blood and urine tests, to make sure taking part is safe and suitable for your specific circumstances.
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.
- I am aged 18 or older.
- I have been diagnosed with an antibody-mediated kidney disease (such as membranous nephropathy).
- I have protein showing up in my urine.
- I am able to attend regular hospital appointments and complete 24-hour urine tests.
- I do not currently have a serious, active infection.
What does participation involve?
Taking part in the trial lasts for up to two years (24 months). During the study, you will receive surovatamig under the supervision of hospital kidney specialists. You will need to attend regular clinic appointments for health checks. These visits will include blood pressure and temperature checks, routine blood tests, heart tracings (ECGs), and 24-hour urine collections to measure protein levels. You will also be asked to fill out short questionnaires about how you are feeling in your daily life. The medical team will support you throughout each step.
Potential risks and benefits
Locations (6)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is the main goal of this study?
To find out if surovatamig is safe and effective at lowering the amount of protein leaking into the urine for people with antibody-related kidney disease.
Will I receive a dummy drug (placebo)?
No. This is an open-label study, meaning every person who joins will receive the active study drug.
How long will I be involved in the study?
Your participation and health monitoring will last for up to 24 months (two years).
What tests will I need to have done?
You will have regular blood tests, 24-hour urine collections, simple heart tracings (ECGs), and general physical examinations.
Can I leave the study early if I want to?
Yes. Taking part is voluntary, and you are free to stop at any time without giving a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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