A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
This research study is testing new medicines for two types of kidney disease: Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD). Both conditions can affect how well your kidneys filter waste from your blood. We want to find out if three new medicines – frexalimab, brivekimig, or rilzabrutinib – can help reduce the amount of protein in your urine and improve your kidney health. This is compared to a 'dummy' medicine (placebo) to truly understand the new treatments' effects. Patients aged 16 to 75 are taking part. The study will look closely at how safe these new medicines are and how well they work over time.
At a glance
What is this study about?
This study is for people aged 16 to 75 who have been diagnosed with one of two specific kidney conditions: Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD). Both of these conditions affect the tiny filters in your kidneys, called glomeruli, which can cause protein to leak into your urine, among other problems. This is often called nephrotic syndrome.
We are testing three new medicines – frexalimab, brivekimig, and rilzabrutinib – to see if they can help reduce this protein leakage and improve your kidney health. To fairly test these medicines, some participants will receive one of the new medicines, while others will receive a 'placebo', which looks like the medicine but contains no active drug. This helps us understand if any changes are truly due to the new treatments. We will carefully watch how much protein is in your urine over time and whether your condition improves.
Finding new and effective treatments for FSGS and MCD is very important because these conditions can significantly impact a person's health and quality of life. By understanding how these potential new medicines work, we hope to offer better options for people living with these kidney diseases in the future.
Key takeaways
- Tests new medicines for FSGS and MCD kidney diseases.
- Compares frexalimab, brivekimig, or rilzabrutinib to a dummy drug (placebo).
- Aims to reduce protein in urine and improve kidney health.
- For adults aged 16-75 with specific kidney conditions.
- Involves regular clinic visits and close health monitoring.
Who may be eligible?
To join this study, doctors would need to confirm you have either primary Focal Segmental Glomerulosclerosis (FSGS) or primary Minimal Change Disease (MCD) based on a kidney biopsy. You would also need to be between 16 and 75 years old.
Researchers will check how much protein is in your urine and how well your kidneys are working (your eGFR). You should also have shown a good response to previous treatments like steroids, meaning your protein levels in your urine went down by more than 40%. If you are already taking certain medications for your kidneys, like steroids, RAAS inhibitors, or SGLT2 inhibitors, their doses need to have been stable for a set period before you join the study. Your weight must be between 45 and 120 kg.
You would not be able to join if your FSGS or MCD is caused by other medical conditions or genetics (though people with certain genetic risk factors called APOL1 are still eligible). Also, if your FSGS is a specific severe type called 'collapsing variant', or if you have kidney failure requiring dialysis or a transplant, you wouldn't be able to take part.
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 between 16 and 75 years old?
- Do you have primary FSGS or primary MCD diagnosed by a kidney biopsy?
- Has your protein in urine (UPCR) been high enough, and do your kidneys work well enough?
- Have you responded well to previous steroid treatment for your kidney condition?
- Are any existing kidney medications you take on a stable dose for a few weeks?
- Is your body weight within a certain range (45 to 120 kg)?
What does participation involve?
If you decide to take part, the study will last for up to 76 weeks in total – that's about a year and a half. For 24 of those weeks, you will be taking one of the study medicines or a placebo. During this time, you will have up to 18 visits to the clinic. These visits are important for the doctors to check on your health, see how the medicine is affecting you, and perform tests like blood and urine samples and blood pressure checks. This routine monitoring helps ensure your safety and allows researchers to collect all the necessary information about the potential effects of the treatments.
Potential risks and benefits
Locations (69)
- Investigational Site Number : 8400007Verified postcodeBirmingham, United States· Recruiting
- Investigational Site Number : 8400015Verified postcodeOrange, United States· Recruiting
- Investigational Site Number : 8400012Verified postcodeSan Francisco, United States· Recruiting
- Investigational Site Number : 8400025Verified postcodeTampa, United States· Recruiting
- Investigational Site Number : 8400014Verified postcodeChicago, United States· Recruiting
- Investigational Site Number : 8400017Verified postcodeHinsdale, United States· Recruiting
- Investigational Site Number : 8400010Verified postcodeAnn Arbor, United States· Recruiting
- Investigational Site Number : 8400019Verified postcodeEdina, United States· Recruiting
- Investigational Site Number : 8400018Verified postcodeLas Vegas, United States· Recruiting
- Investigational Site Number: 8400028Verified postcodeAlbuquerque, United States· Recruiting
- Investigational Site Number : 8400001Verified postcodeNew York, United States· Recruiting
- Investigational Site Number : 8400021Verified postcodeChapel Hill, United States· Recruiting
Common questions
What are FSGS and MCD?
These are types of kidney disease where the filters in your kidneys (glomeruli) don't work properly, leading to protein leaking into your urine.
What does 'Phase 2' mean for a study?
Phase 2 means the new medicines are being tested in a small group of people to see if they are safe and if they show promise in treating the condition.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly making a difference.
How long will I be taking the study medicine?
You would be taking the study medicine (or placebo) for 24 weeks, which is about 6 months.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without any impact on your ongoing medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.