AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized controlled, two-arm (1:1 ratio) Phase IIa trial to assess the efficacy and safety of obinutuzumab in treating adults with de novo minimal change disease

This study is looking at a new medicine called obinutuzumab for adults who have a kidney problem called minimal change disease. We want to find out if obinutuzumab works as well as the usual steroid treatments to help people feel better. We are also checking if it's better at keeping the disease from coming back over a year. The study will compare obinutuzumab with common medicines like prednisolone, and will carefully watch for any side effects. Our goal is to see if this new treatment can offer a safe and effective way to manage minimal change disease.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medizinische Universitaet Innsbruck

Enrolment target

Start

23 Apr 2026

Kidney disease

What is this study about?

This study is for adults who have a kidney condition called minimal change disease (MCD). In MCD, your kidneys don't work properly and leak important proteins from your blood into your urine. This can make you feel tired and swollen.

We are testing a new medicine called obinutuzumab, also known as Gazyvaro, against the current standard treatments, which often involve steroid medications like prednisolone. We want to find out if obinutuzumab is just as good, or even better, at helping your kidneys recover. We're also checking if it can help prevent the disease from returning over a year. Throughout the study, we will be carefully monitoring how well the treatment works and if there are any side effects.

The main aim is to see if obinutuzumab can lead to remission, meaning your symptoms improve or disappear, within the first 8 weeks. We're also studying if it can help you stay in remission for a longer time, up to 52 weeks, compared to current treatments. This research is important because it could lead to new and better ways to treat minimal change disease, potentially reducing the need for long-term steroid use and its associated side effects.

Key takeaways

This study is testing a new medicine called obinutuzumab for minimal change disease.
It compares obinutuzumab to current standard treatments like steroids.
The study aims to see if the new medicine works as well or better and is safe.
Participation involves regular clinic visits, tests, and taking either the new or standard treatment.
The study lasts for about a year and is open to adults of all ages.
This research could lead to new options for treating minimal change disease.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit, so people of all adult ages can consider joining.

Both men and women are welcome to take part in this study. The researchers want to understand how the new medicine works in everyone with minimal change disease.

If you have minimal change disease, are an adult, and are interested in potentially trying a new treatment while helping medical research, you might be a good fit. More detailed checks will be done by the study team to make sure it's safe and appropriate 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 18 years old or older?
Have you been diagnosed with minimal change disease?
Are you able to attend regular clinic appointments for about a year?
Are you willing to potentially receive either the new medicine or a standard treatment?
Do you understand that this is a research study and not a guaranteed treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups: one will receive the new medicine, obinutuzumab, and the other will receive standard treatments, which may include medicines like prednisolone, tacrolimus, or rituximab. This is decided by chance, like flipping a coin. You will receive infusion treatments, which means the medicine is given directly into your vein.

Over the course of 52 weeks (about a year), you will have regular visits to the clinic. During these visits, the study team will perform various tests. These will likely include blood and urine tests to check your kidney function and protein levels, and to monitor for any side effects. You may also be asked to complete questionnaires about how you are feeling and your quality of life. The total duration of active treatment and follow-up for the study is about one year.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as access to a new treatment before it's widely available and receiving close medical attention. However, there are also potential risks, including side effects from the study medicines, which will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Austria
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Unverified
France

Common questions

What is minimal change disease?

Minimal change disease is a kidney condition where your kidneys leak protein, causing swelling and other symptoms.

What is obinutuzumab (Gazyvaro)?

Obinutuzumab is an experimental medicine being tested to see if it can help treat minimal change disease.

Will I definitely receive the new medicine?

No, you might receive the new medicine or the standard treatment. Which one you get is decided by chance.

How long will the study last?

The study will last for about 52 weeks, which is roughly one year.

What are 'standard treatments'?

Standard treatments are the usual medicines doctors currently use for minimal change disease, such as steroids like prednisolone.