AuthorisedTherapeutic exploratory (Phase II)Interventional

Obinutuzumab induced decreases of PLA2Rab in MN: a pilot study

This study is investigating a new medication called Gazyvaro (obinutuzumab) for adults with a kidney condition known as primary membranous nephropathy. This condition happens when the body's immune system mistakenly attacks the kidneys, leading to problems. Researchers want to understand how effectively Gazyvaro can lower the levels of specific antibodies (called PLA2R antibodies) that play a key role in this disease. They will also be checking if the treatment helps the kidneys recover, improves overall health, and how patients feel during the treatment. This is a pilot study, meaning it's an early step to gather information about this new approach before larger studies are done. The main goal is to see if the antibodies disappear or decrease over time.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

31 Jul 2025

Primary membranous nephropathy

What is this study about?

This research study is about a kidney condition called primary membranous nephropathy. In this condition, your body's immune system, which normally fights off infections, mistakenly attacks tiny filters in your kidneys. This can lead to your kidneys not working as well as they should.

The study is testing a medicine called Gazyvaro, also known by its active ingredient obinutuzumab. This medicine is given through a drip (infusion). Researchers want to find out how well Gazyvaro can reduce the levels of certain substances in your blood called anti-PLA2R antibodies. These antibodies are thought to be a major cause of primary membranous nephropathy. By lowering these antibodies, the hope is to reduce the harm to your kidneys and improve your health.

This is an early-stage study, sometimes called a Phase II study. This means it's one of the first human trials to see if the treatment is safe and if it shows promise in treating the condition. They will be carefully watching to see if the antibodies go away or decrease, if your kidney function improves, and how you feel overall during the treatment.

Key takeaways

This study is testing a new medicine called Gazyvaro for primary membranous nephropathy.
It aims to reduce specific antibodies (PLA2R) that cause the kidney disease.
Researchers will check if kidney function improves and how patients' quality of life is affected.
This is an early-stage study, gathering important information about the treatment.
It's open to adults aged 18 and over, of any gender, diagnosed with the condition.

Who may be eligible?

This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.

To be considered for this study, you must have a specific kidney condition called primary membranous nephropathy. The doctors will need to confirm this diagnosis.

There might be other health checks or specific requirements your doctor will discuss with you to make sure this study is the right fit for your health situation.

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 a diagnosis of primary membranous nephropathy?
Are you able to attend regular hospital appointments for infusions and tests?
Are you comfortable with receiving an experimental medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the study medicine, Gazyvaro, through an intravenous drip. This means the medicine will be given directly into your bloodstream. You would need to attend regular appointments at the hospital or clinic for these infusions and for various tests.

These tests will likely include blood samples to check your body's response to the treatment, especially how your anti-PLA2R antibodies are changing. Doctors will also monitor your kidney function to see if it improves, and they will ask questions about your general health and how you are feeling to understand your quality of life. The total duration of your participation, including follow-up appointments, will be clearly explained to you by the study team.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new treatment that could improve your kidney condition, and you will be closely monitored by medical professionals. However, as with any medication, there are potential risks and side effects associated with Gazyvaro, which the study team will fully explain. You will receive detailed information about these before you decide to join. Remember, your participation is completely voluntary, and 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
Netherlands

Common questions

What is primary membranous nephropathy?

It's a kidney disease where your body's immune system attacks your kidneys, causing problems with their filtering ability.

What is Gazyvaro (obinutuzumab)?

It's a medication being tested in this study, given by an IV drip, to see if it can treat primary membranous nephropathy.

What are 'antibodies' in this study?

They are substances in your blood. In this disease, specific antibodies (PLA2R) mistakenly attack the kidneys.

Will this treatment cure my condition?

This is an early study to see if the treatment can reduce the disease-causing antibodies and improve kidney function, but it's not guaranteed to be a cure.

What does 'Phase II study' mean?

It means it's an early-stage study to learn more about a new treatment's safety and effectiveness before larger studies.