AuthorisedTherapeutic exploratory (Phase II)Interventional

PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

This research study, called PODOMOUNT-Basket, is testing a new medicine called BI 764198 for several kidney diseases where your kidneys leak too much protein into your urine. This is a "Phase II" study, meaning we're still in the earlier stages, checking if the medicine is safe, how well your body handles it, and if it might help. Participants will be randomly given either the new medicine or a dummy pill (placebo), without knowing which one they receive. We will closely monitor the amount of protein in their urine over about 20 weeks to see if the medicine makes a difference. The main goal is to see if the new medicine reduces the amount of protein in the urine compared to the dummy pill.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Enrolment target

Start

19 May 2026

Proteinuric kidney diseases

What is this study about?

This study is called PODOMOUNT-Basket, and it's looking into a new medicine, BI 764198, for certain kidney conditions where your kidneys aren't working quite right and allow too much protein to pass into your urine. This is a common problem in several kidney diseases and can be a sign that your kidneys are struggling. Finding ways to reduce this protein can be very important for keeping your kidneys healthier for longer.

Because this is a "Phase II" study, it means we're still in the relatively early stages of testing this new medicine. We want to see several things: first, if the medicine is safe for people to take; second, how your body processes the medicine (this is called 'PK' or pharmacokinetics); and third, if it actually helps to reduce the amount of protein in your urine. We will compare the new medicine to a 'placebo', which is a dummy pill that looks exactly like the real medicine but contains no active drug. This helps us to understand if any effects we see are truly due to the medicine or just a coincidence.

Participants will be placed into one of two groups by chance (randomly) – one group will get the new medicine, and the other will get the placebo. Neither you nor the study team will know which you are receiving, which helps us get the most accurate results. We will be especially interested in measuring the protein levels in your urine at the start and then again after about 20 weeks to see if the medicine has made a difference. We'll also be looking at other measures of kidney health.

Key takeaways

This study is testing a new medicine (BI 764198) for certain kidney diseases causing protein in urine.
It's a Phase II study, checking safety, how the body handles the medicine, and potential benefits.
Participants will receive either the new medicine or a dummy pill, decided by chance.
The main goal is to see if the medicine reduces protein in urine over about 20 weeks.
All adults (18+) with specific proteinuric kidney diseases are welcome to inquire.
Regular clinic visits, blood tests, and urine tests will be part of taking part.

Who may be eligible?

To be able to join this study, you need to be an adult, 18 years of age or older. We are looking for both men and women to participate.

The study is specifically for people who have one of several kidney diseases that cause a lot of protein to leak into their urine. The doctors will do tests to confirm you have this kind of kidney problem and that your kidney function meets certain requirements.

There will be other specific health checks to make sure the study medicine is safe for you and that you don't have any other serious health conditions that might interfere with the study results.

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 a kidney condition that causes protein to leak into your urine?
Are you able to attend regular clinic appointments for about 20 weeks?
Are you willing to take study medication and have blood and urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to either receive the new medicine, BI 764198, or a dummy pill (placebo). Neither you nor your study doctor will know which you are receiving throughout the initial study period. You will take the study medication regularly as instructed.

Taking part will involve regular visits to the clinic over a period of about 20 weeks. During these visits, the study team will carry out various checks and assessments. This will include blood tests, urine tests (especially to measure protein), and checks of your overall health and how you are feeling. You will also have follow-up appointments after the main treatment period to ensure your safety and monitor your health. The total duration of your involvement, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new medicine that could help your kidney condition, though there's no guarantee the medicine will work for you. There are always potential risks with new medicines, which could include side effects or unexpected reactions. The study team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

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

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Unverified
Portugal
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Unverified
Greece
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Italy
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Unverified
Poland
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Unverified
Estonia
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Unverified
Slovakia
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Unverified
Sweden
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Unverified
Denmark
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Unverified
Belgium
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Unverified
Norway
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Unverified
Romania
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Unverified
France

Common questions

What is proteinuric kidney disease?

It's a type of kidney disease where your kidneys unfortunately let too much protein leak out of your blood and into your urine. This can be a sign that your kidneys aren't working as well as they should.

What does 'double-blind' mean?

It means that neither you nor the doctors treating you will know if you are receiving the new medicine or the dummy pill (placebo). This helps make the study results as fair and accurate as possible.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps us compare the effects of the new medicine against no treatment, to see if the medicine truly makes a difference.

How long will I be in the study?

The main part of the study where we check your urine protein levels will last about 20 weeks, but your full involvement, including follow-up visits, will be explained by the study team.

What is the main thing the study is looking for?

The main goal is to see if the new medicine, BI 764198, reduces the amount of protein in your urine after 20 weeks compared to the dummy pill.