A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
This study is investigating a new medication called BI 764198 for adults and young people (aged 12 and over) who have a kidney condition known as Focal Segmental Glomerulosclerosis (FSGS). FSGS can affect how well your kidneys filter waste from your blood. The main goal of this research is to discover if BI 764198 can help improve the health of kidneys in people with FSGS. Participants will be put into two groups by chance: one group will receive the new medicine, and the other will receive a dummy pill (placebo). Both groups will continue their usual FSGS medication. The study involves taking a tablet once a day for up to two years and having regular check-ups to monitor kidney function and overall health.
At a glance
What is this study about?
This study is designed to explore whether a new medicine, called BI 764198, can help people who have a kidney condition called Focal Segmental Glomerulosclerosis (FSGS). FSGS is a condition where tiny filters in the kidneys, which clean your blood, become scarred. This scarring can make it harder for your kidneys to work properly and can lead to kidney damage over time. The researchers want to find out if BI 764198 can slow down or stop this damage.
Taking part in this study means you would be trying a new treatment that isn't yet widely available. The study is particularly interested in people aged 12 and over. It's a 'Phase 3' study, which means the medicine has already been tested in smaller groups, and now researchers need to confirm its safety and effectiveness in a larger group of people. This is an important step to see if BI 764198 could become a future treatment option for FSGS.
By comparing BI 764198 to a placebo (a tablet with no active medicine), researchers can accurately tell if any changes in your health are due to the study medicine or other factors. This careful approach helps them make sure any benefits found are real and not just by chance. Your participation would provide valuable information that could help many others with FSGS in the future.
Key takeaways
- This study evaluates a new medication (BI 764198) for FSGS.
- It involves adults and young people (12+ years) with specific types of FSGS.
- Participants take a daily tablet for up to two years.
- Half receive the medicine, half receive a dummy pill (placebo).
- Regular kidney checks and health monitoring are part of the study.
- Your regular FSGS medicines will be continued throughout the trial.
Who may be eligible?
This study is looking for both adults and young people, starting from 12 years old, who have been diagnosed with Focal Segmental Glomerulosclerosis (FSGS). To be considered, your FSGS must be either the 'primary' type (meaning it's not caused by another specific illness) or a genetic type linked to a particular gene change (called TRPC6 gain-of-function mutation).
There are also some health requirements. Your kidney function needs to be within a certain range, which doctors will check with blood and urine tests. You should also weigh at least 40 kg (about 6 stone 4 pounds) and have a body mass index (BMI) of 40 or under.
However, you wouldn't be able to join if your FSGS has a different known genetic cause or if it's considered a 'secondary' type caused by other health issues. Also, if you've had an organ transplant or are planning one, or if you've recently used certain strong medications that affect your immune system, you wouldn't be eligible. The clinical team will review all your detailed medical information to see if this study is suitable 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 12 years old or older?
- Have you been diagnosed with primary FSGS or a specific genetic type of FSGS (TRPC6 mutation)?
- Do you weigh at least 40 kg and have a BMI of 40 or less?
- Have you *not* had an organ transplant or are planning one?
- Have you *not* recently taken certain strong immune-suppressing medications?
What does participation involve?
If you join the study, you would take a tablet once a day for up to two years. Half the participants will get the actual study medicine, BI 764198, and the other half will get a placebo (a dummy pill that looks the same but has no medicine). You won't know which one you're taking. It's important to continue taking any other standard medications you currently use for your FSGS.
During these two years, you would visit the study clinic about once every three months for check-ups. These visits will involve doctors checking your general health and looking out for any unwanted effects the medicine might be causing. You'll also need to provide urine samples regularly, which helps the doctors monitor how your kidneys are working. By comparing these results between the two groups, the researchers can see if the new treatment is helping. You are free to leave the study at any time.
Potential risks and benefits
Locations (271)
- Alabama Kidney ResearchVerified postcodeAlabaster, United States· Not yet recruiting
- Apogee Clinical ResearchVerified postcodeHuntsville, United States· Not yet recruiting
- Southwest Kidney InstituteVerified postcodeSurprise, United States· Not yet recruiting
- West Coast Kidney InstituteVerified postcodeFremont, 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
- Valiance Clinical ResearchVerified postcodeHuntington Park, United States· Not yet recruiting
- Academic Medical Research Institute - GlendaleVerified postcodeLos Angeles, United States· Recruiting
- Kaiser Permanente - Los Angeles Medical CenterVerified postcodeLos Angeles, United States· Not yet recruiting
- University of California Los AngelesVerified postcodeLos Angeles, United States· Not yet recruiting
- North America Research InstituteVerified postcodeSan Dimas, United States· Not yet recruiting
- Kaiser Permanente - French CampusVerified postcodeSan Francisco, United States· Not yet recruiting
Common questions
What is FSGS?
FSGS stands for Focal Segmental Glomerulosclerosis. It's a kidney condition where small filters in your kidneys become scarred, which can stop them from working as well as they should.
What is a placebo?
A placebo is a 'dummy' pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare how well the real medicine works.
How long will I be in the study?
You would be in the study for up to two years. During this time, you'll have regular check-ups at the study clinic.
Will I still take my regular FSGS medication?
Yes, all participants in the study will continue to take their usual prescribed medication for FSGS alongside the study treatment.
Can I leave the study if I want to?
Absolutely, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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?
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