A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
This study is looking into a new medicine called Surovatamig for adults who have a specific kidney condition known as Primary Membranous Nephropathy. In this condition, the kidneys don't work as well as they should because tiny filters become damaged. The study wants to see if Surovatamig, given as an injection under the skin, is safe, how the body uses it, and if it can help improve kidney function. This is an important step because some people with this condition are at high risk of their kidneys getting much worse. Researchers will follow participants for up to 26 months, learning more about this potential new treatment.
At a glance
What is this study about?
This research study is about a new medicine called Surovatamig. Doctors are hoping this medicine could help adults who have a kidney disease called Primary Membranous Nephropathy (pMN). In pMN, the kidneys' tiny filters (called glomeruli) get damaged, often because the body's immune system mistakenly attacks them. This can lead to too much protein leaking into the urine, which is a sign the kidneys aren't working properly. If not managed, this condition can get much worse for some people, potentially leading to serious kidney failure.
The main goal of this study is to find out more about Surovatamig. Researchers want to see if it's safe to use, how the body handles the medicine, and if it can actually help people with pMN. It's given as an injection just under the skin. This study is an important step in developing new treatments, especially for those patients at higher risk of their kidney disease getting worse.
This study will take place in many hospitals across about 10 different countries, with up to 40 study locations. It will last for up to 26 months for each person taking part. During this time, participants will be carefully monitored, and doctors will collect information to understand how Surovatamig works and how well it helps control the kidney disease.
Key takeaways
- Tests a new medicine, Surovatamig, for a kidney disease called Primary Membranous Nephropathy.
- Aims to check safety, how the body handles the medicine, and if it helps kidney function.
- Involves adults (18-75 years old) with a specific type of this kidney disease.
- Medicine is given as an injection under the skin.
- Participation lasts up to 26 months with regular check-ups.
- Important for those at high risk of their kidney disease worsening.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old. Doctors will need to have diagnosed you with a specific type of kidney disease called Primary Membranous Nephropathy, and tests must show you have particular antibodies (anti-PLA2R) in your blood. You should also be taking standard medicines for your kidney condition, like ACE inhibitors or ARBs, unless you can't take them for medical reasons. It's important that your vaccinations, such as for flu and COVID-19, are up to date.
There are also some reasons why you might not be able to join. For example, if you've recently had certain immune-system treatments in the last few months, or if you have other serious health problems like uncontrolled diabetes, certain types of cancer, or specific heart, lung, or brain conditions. If you're currently taking high doses of steroid medication, this might also mean you can't take part. The study team will carefully check all your health information to see if this study is 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 between 18 and 75 years old?
- Have you been diagnosed with Primary Membranous Nephropathy and tested positive for anti-PLA2R antibodies?
- Are you generally taking standard medicines for your kidney condition (e.g., ACE inhibitors/ARBs)?
- Are your vaccinations, such as flu and COVID-19, up to date?
- Have you avoided certain immune treatments in the last 9 months?
- Do you have good overall health without specific serious medical conditions like uncontrolled diabetes or certain cancers?
What does participation involve?
If you decide to join this study, it will be divided into different parts and will last for up to 26 months. First, there's a screening period where doctors will do tests to make sure the study is suitable for you. After that, if you qualify, you'll enter the treatment period where you'll receive the study medicine, Surovatamig, given as an injection under your skin. You'll have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how the medicine is affecting your kidney disease. There will also be a follow-up period after you finish taking the medicine to continue monitoring your health and gather more information.
Potential risks and benefits
Locations (21)
- Research SiteVerified postcodeLos Angeles, United States· Not yet recruiting
- Research SiteVerified postcodeIowa City, United States· Not yet recruiting
- Research SiteVerified postcodeBethesda, United States· Not yet recruiting
- Research SiteVerified postcodeNew York, United States· Not yet recruiting
- Research SiteVerified postcodeHouston, United States· Recruiting
- Research SiteVerified postcodeHouston, United States· Not yet recruiting
- Research SiteVerified postcodeIeper, Belgium· Not yet recruiting
- Research SiteVerified postcodeBordeaux, France· Not yet recruiting
- Research SiteVerified postcodeCréteil, France· Withdrawn
- Research SiteVerified postcodeLyon, France· Not yet recruiting
- Research SiteVerified postcodeNantes, France· Not yet recruiting
- Research SiteVerified postcodeNîmes, France· Not yet recruiting
Common questions
What is Primary Membranous Nephropathy?
It's a kidney disease where the tiny filters in your kidneys get damaged, often causing protein to leak into your urine.
What is Surovatamig?
It's a new medicine being tested in this study to see if it can help treat Primary Membranous Nephropathy.
How will I take Surovatamig?
It will be given as an injection under your skin, similar to an insulin shot.
How long does the study last?
If you join, the study will last for up to 26 months, including screening, treatment, and follow-up.
Will I still take my regular kidney medicines?
Yes, you generally need to be taking standard medicines for your kidney condition before and during the study.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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