A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.
This study is investigating a new oral medicine, BI 764198, for adults with a specific kidney disease called focal segmental glomerulosclerosis (FSGS). FSGS causes scarring in the kidneys and can lead to kidney failure. Over 12 weeks, some participants will receive the new medicine, while others will get a placebo (a dummy pill that looks the same but has no active ingredient). This helps us understand if the new medicine is truly effective. We'll be checking how well it reduces protein in the urine, which is a key sign of kidney damage in FSGS, and also monitoring its safety and how the body handles it. Your participation could help us learn if this new treatment could be an option for FSGS patients in the future.
At a glance
What is this study about?
This study is all about a new medicine called BI 764198, which we're hoping could help people with a specific type of kidney disease called focal segmental glomerulosclerosis (FSGS). In FSGS, the tiny filters in your kidneys, called glomeruli, become scarred and damaged. This damage means your kidneys don't work as well as they should, leading to protein leaking into your urine. Over time, this can lead to serious kidney problems.
We want to find out two main things about BI 764198: firstly, how well it works to reduce the amount of protein in the urine, and secondly, if it's safe and doesn't cause too many side effects. To do this, we're comparing it to a 'placebo', which is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. Having a placebo group helps us know if any improvements we see are genuinely due to the new medicine, or if they might have happened anyway.
Participants in the study will take the medicine (or the placebo) once a day for 12 weeks. Throughout this time, we'll regularly check your urine to measure the protein levels. We'll also take blood samples to see how your body handles the medicine and to keep an eye on your overall health. The results from this study will help us understand if BI 764198 could be a good treatment option for people with FSGS in the future.
Key takeaways
- This study is testing a new medicine for Focal Segmental Glomerulosclerosis (FSGS).
- It aims to see if the medicine reduces protein in urine and is safe.
- Participants will take medicine (or a dummy pill) for 12 weeks.
- Regular urine and blood tests will be taken to monitor progress.
- It's a 'blinded' study, so you won't know if you're getting the active drug or placebo.
Who may be eligible?
This study is looking for adults aged 18 or over. Both men and women can take part.
Because FSGS can affect people differently, the study team will also need to check other things about your health and your FSGS. This is to make sure the study medicine is right for you and that you'll be safe taking part. For example, they'll check your kidney function and other medical conditions you might have.
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 Focal Segmental Glomerulosclerosis (FSGS)?
- Are you able to take medicine by mouth once a day?
- Are you generally healthy enough to participate in a clinical study?
What does participation involve?
If you decide to take part, you would be involved for 12 weeks, taking the study medicine (or placebo) once a day. You'll have several visits to the clinic during this time. These visits will involve blood tests and urine tests to measure your protein levels and see how your kidneys are doing. We'll also ask you questions about how you're feeling and check for any side effects. After the 12 weeks of treatment, there will be a final follow-up visit. The study team will explain everything in detail, including how long each visit might take.
Potential risks and benefits
Locations (5)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is FSGS?
FSGS stands for Focal Segmental Glomerulosclerosis. It's a disease where parts of the kidney's filters become scarred, leading to protein leaking into the urine and eventually damaging the kidneys.
What is a 'placebo'?
A placebo is a 'dummy pill'. It looks exactly like the study medicine but doesn't contain any active drug. We use it to compare against the real medicine to see if the new drug actually works.
How long will I be taking the medicine?
If you join the study, you'll be taking the study medicine (or placebo) once a day for 12 weeks.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is called 'double-blinded' and helps ensure the study results are fair.
What kind of tests will I have?
You'll have regular urine tests to measure protein levels and blood tests to check your kidney function and how your body is reacting to the possible medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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