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
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.
- Are you 18 or older (or 12-17 with specific Minimal Change Disease)?
- Is your weight at least 40 kg (about 6 stone 4 pounds)?
- Is your BMI 40 or less?
- Are you on a stable dose of certain kidney medications (like ACE inhibitors or ARBs) for at least 8 weeks?
- Is your blood pressure usually within healthy limits for your age?
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
Locations (155)
- Nephrology Consultants, LLCVerified postcodeHuntsville, United States· Not yet recruiting
- Kidney Disease Medical GroupVerified postcodeGlendale, United States· Not yet recruiting
- Amicis Research Center - BalboaVerified postcodeGranada Hills, United States· Not yet recruiting
- Academic Medical Research Institute - GlendaleVerified postcodeLos Angeles, United States· Not yet recruiting
- University of California Los AngelesVerified postcodeLos Angeles, United States· Not yet recruiting
- Colorado Kidney CareVerified postcodeDenver, United States· Not yet recruiting
- Florida Kidney Physicians - Boca RatonVerified postcodeBoca Raton, United States· Not yet recruiting
- Florida Kidney Physicians, LLC - Fort LauderdaleVerified postcodeFort Lauderdale, United States· Not yet recruiting
- Total Research Group, LLCVerified postcodeMiami, United States· Not yet recruiting
- CTR Oakwater, LLCVerified postcodeOrlando, United States· Not yet recruiting
- Panoramic HealthVerified postcodeRiverview, United States· Not yet recruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoVerified postcodeChicago, 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?
Discussion
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