A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)
This research study is investigating a new medication, Sparsentan, for adults diagnosed with a specific kidney disease called Focal Segmental Glomerulosclerosis (FSGS). The main goal is to see if Sparsentan can slow down kidney damage better than a commonly used medication, Irbesartan. Researchers will carefully check how well the kidneys are working over approximately two years, looking at how quickly kidney function might decline. They will also measure how much protein is in the urine, as this is a sign of kidney problems. Importantly, the study will also look closely at any side effects to make sure the treatment is safe for patients. This is a crucial step in understanding if Sparsentan could be a new and effective treatment option for FSGS.
At a glance
What is this study about?
This study is a clinical trial looking into a new medication called Sparsentan for people who have a kidney condition called Focal Segmental Glomerulosclerosis, often shortened to FSGS. FSGS is a serious disease where parts of the kidney's filtering units get scarred. This scarring can lead to protein leaking into the urine and, over time, can cause significant kidney damage, potentially leading to kidney failure.
The main purpose of this research is to find out if Sparsentan can help protect the kidneys and slow down the progression of FSGS more effectively than a medication that's already used for kidney conditions, called Irbesartan. Researchers will be carefully monitoring how well participants' kidneys are working by checking their kidney function over a period of about two years. They will also look at how much protein is in the urine, as a reduction in protein can be a good sign that the kidneys are being protected.
By comparing Sparsentan to existing treatment, the study aims to understand if this new drug could offer a better way to manage FSGS. The results will help doctors decide if Sparsentan should be more widely used to help people with this kidney condition. This is a 'Phase III' study, which means it's one of the final stages of testing before a new medication might become available to the public, building on earlier research that showed promise.
Key takeaways
- The study is investigating a new medication called Sparsentan for FSGS.
- It compares Sparsentan with an existing drug, Irbesartan, to see which is better.
- The main focus is on protecting kidney function and reducing protein in urine.
- The study will last approximately two years, with regular check-ups.
- It's a Phase III study, a final step before potential public availability.
- Patient safety and well-being are closely monitored throughout.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
Beyond these basic requirements, there will be other specific medical conditions and test results that the medical team will need to check to make sure the study is a good fit for you and that it's safe for you to take part. For example, they will need to confirm your diagnosis of FSGS and ensure your overall health meets certain criteria.
It's important to understand that even if you meet the age and sex requirements, there might be other reasons why you wouldn't be able to join the study. This is to ensure the safety of all participants and to make sure the research results are clear and accurate.
- Are you 18 years old or older?
- Do you have a diagnosis of Focal Segmental Glomerulosclerosis (FSGS)?
- Are you able to attend regular clinic visits for about two years?
- Are you willing to potentially receive either a new drug or a standard treatment?
- Are you generally in good health, apart from your FSGS, according to your doctor?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either the new medication, Sparsentan, or a standard treatment called Irbesartan. You wouldn't know which one you are receiving, and neither would your study doctor, until the very end of the main part of the study. This helps ensure fairness and accuracy in the results. The main part of the study will last for about two years, and you would need to attend regular visits to the study clinic for check-ups, blood and urine tests, and to get your medication. These visits will allow the medical team to monitor your kidney function, check for any side effects, and see how you are doing overall.
After the initial two years, there is a possibility of continuing in an 'open-label' part of the study. In this extension, everyone would know they are receiving Sparsentan. During this extended period, ongoing check-ups would continue, including blood tests to monitor kidney function, cholesterol levels, and other health markers, as well as checks for any side effects. You would also be asked about your general well-being and any changes in your quality of life. The total duration of your involvement could extend beyond two years if you decide to join the open-label extension.
Potential risks and benefits
Locations (12)
- —Germany
- —Belgium
- —France
- —Spain
- —Czechia
- —Croatia
- —Denmark
- —Sweden
- —Portugal
- —Estonia
- —Poland
- —Italy
Common questions
What is FSGS?
FSGS stands for Focal Segmental Glomerulosclerosis. It's a type of kidney disease where the tiny filters in your kidneys become scarred, which can lead to protein leaking into your urine and eventually damage your kidneys.
What is Sparsentan?
Sparsentan is a new medication being tested. It's designed to help protect the kidneys in people with conditions like FSGS by blocking certain substances in the body.
What's the difference between Sparsentan and Irbesartan?
Irbesartan is an existing medication often used for high blood pressure and kidney conditions. Sparsentan is a new drug with a potentially different way of working, and this study compares how well they both work for FSGS.
Why don't I know which medication I'm taking?
This is called a 'double-blind' study. It helps make sure that the results are fair and objective, as neither you nor your doctor will know who is getting which treatment until the study is over. This prevents any bias.
How long will I be in the study?
The main part of the study will last for about two years. There might be an option to continue in an extended part of the study after that, if you choose.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.