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RecruitingPHASE2INTERVENTIONAL

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

This study, called PODOMOUNT-Basket, is testing a new medicine called BI 764198 for people with specific kidney conditions. These include certain types of Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Alport Syndrome, and Membranous Nephropathy. Both adults and some teenagers with these conditions can take part. The main goal is to see if BI 764198 helps reduce protein in the urine and improves kidney function. Participants will take either the study medicine or a dummy pill (placebo) once a day for 20 weeks, alongside their usual kidney medicines. Doctors will regularly check their kidney health through urine and blood tests, and monitor for any side effects.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Boehringer Ingelheim
Enrolment target
132
Start
23 Mar 2026
Estimated completion
17 Feb 2028

What is this study about?

This study is called PODOMOUNT-Basket, and it's looking into a new medicine called BI 764198. The main aim is to find out if this medicine can help adults and some teenagers who have particular kidney problems. These conditions include specific forms of secondary focal segmental glomerulosclerosis (sFSGS), minimal change disease (TR-pMCD) that hasn't responded to usual treatments, Alport Syndrome (AS), and primary membranous nephropathy (TR-pMN) that's also been difficult to treat.

Having kidney disease can be challenging, and researchers are always looking for better ways to manage these conditions. This study hopes to understand if BI 764198 can make a positive difference by, for example, reducing the amount of protein that leaks into the urine – a common sign of kidney issues. If successful, this medicine could offer a new treatment option for people living with these specific kidney diseases.

It's important to remember that this is a research study. This means we don't yet know if BI 764198 works or if it's better than current treatments. By taking part, you would be helping doctors learn more about these kidney conditions and potentially helping future patients.

Key takeaways

  • The study is testing a new medicine (BI 764198) for certain kidney diseases.
  • It involves taking a pill daily for 20 weeks, alongside your usual medication.
  • Participation includes 6 clinic visits and 3 phone calls over 7 months.
  • You might receive the new medicine or a dummy pill (placebo).
  • Doctors will monitor your kidney health with regular urine and blood tests.
  • You can stop participating at any time.

Who may be eligible?

This study is mainly for adults aged 18 and over with certain kidney conditions. However, teenagers aged 12 and above who have a type of kidney disease called Minimal Change Disease (MCD) that hasn't responded to other treatments can also be considered.

To be eligible, your weight needs to be at least 40 kg, and your Body Mass Index (BMI) should be 40 or less. Your kidneys should also be working at a certain level, which doctors will check with a specific blood test. Your blood pressure needs to be within certain limits when measured by the study doctors.

If you're already taking certain kidney medications, like ACE inhibitors or ARBs, you must have been on a stable dose for at least 8 weeks before joining. The same applies to other medications like MRAs, ERAs, GLP-1s, or SGLT2 inhibitors.

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.

  1. Are you 18 or older (or 12-17 with specific Minimal Change Disease)?
  2. Is your weight at least 40 kg (about 6 stone 4 pounds)?
  3. Is your BMI 40 or less?
  4. Are you on a stable dose of certain kidney medications (like ACE inhibitors or ARBs) for at least 8 weeks?
  5. Is your blood pressure usually within healthy limits for your age?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be in it for about 7 months in total. You'll be asked to visit the study clinic 6 times during this period, and there will also be 3 phone calls with the study team. You'll be given either the study medicine, BI 764198, or a dummy pill (placebo), which looks identical but contains no medicine. There's a higher chance (twice as high) of getting the actual study medicine than the dummy pill.

Both the study medicine and the dummy pill are taken as tablets once a day for 20 weeks. Throughout the study, you'll continue to take your usual kidney medications as prescribed by your doctor. The study team will regularly check your health, which includes providing urine samples to measure protein levels and having blood samples taken to check your kidney function. They will also carefully record any side effects you might experience.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the new medicine, BI 764198, might improve your kidney condition by reducing protein in your urine or improving kidney function. However, there's also a chance you might receive the dummy pill and not the active medicine. As with any drug, BI 764198 might cause side effects, and the study team will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (155)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nephrology Consultants, LLC
    Verified postcode
    Huntsville, United States· Not yet recruiting
  • Kidney Disease Medical Group
    Verified postcode
    Glendale, United States· Not yet recruiting
  • Amicis Research Center - Balboa
    Verified postcode
    Granada Hills, United States· Not yet recruiting
  • Academic Medical Research Institute - Glendale
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • University of California Los Angeles
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Colorado Kidney Care
    Verified postcode
    Denver, United States· Not yet recruiting
  • Florida Kidney Physicians - Boca Raton
    Verified postcode
    Boca Raton, United States· Not yet recruiting
  • Florida Kidney Physicians, LLC - Fort Lauderdale
    Verified postcode
    Fort Lauderdale, United States· Not yet recruiting
  • Total Research Group, LLC
    Verified postcode
    Miami, United States· Not yet recruiting
  • CTR Oakwater, LLC
    Verified postcode
    Orlando, United States· Not yet recruiting
  • Panoramic Health
    Verified postcode
    Riverview, United States· Not yet recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Verified postcode
    Chicago, United States· Not yet recruiting

Common questions

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 doctors compare the real medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know directly. This is called 'blinding' and helps ensure the study results are accurate and unbiased.

How long will I be taking the study tablets?

You will take the tablets once a day for about 20 weeks, which is roughly 5 months.

Can I stop my other kidney medicines during the study?

No, you must continue taking your usual kidney medicines as prescribed by your doctor throughout the study.

What happens if I decide I don't want to continue in the study?

You can leave the study at any time, for any reason, and it will not affect your relationship with your doctors or your future medical care.

How to find out more

Boehringer Ingelheim

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Ad…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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