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Questions about sparsentan (FILSPARI)
Sparsentan (FILSPARI) is a prescription medicine approved by the FDA to reduce proteinuria in adults and children 8 years of age and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome.
Sparsentan is also approved to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression
Sparsentan helps lower the amount of protein leaking into the urine (called proteinuria) without suppressing the immune system.
Protein in the urine is a sign that the kidneys are being damaged. By lowering protein levels in the urine, sparsentan helps protect the kidneys and may help slow how quickly the disease gets worse and decline in kidney function.
Sparsentan works to block cells in the body from making two proteins that are believed to contribute to kidney damage: endothelin and angiotensin II. These two proteins play a key role in pathways that are known to create a harmful cycle with urine protein. For example, endothelin is thought to be involved in inflammation that can damage and scar kidney filters. Blocking these two proteins is protective for the kidneys and helps to reduce urine protein.
Sparsentan is an oral treatment (taken by mouth). It is a non-immunosuppressive medication. That means it does not suppress your immune system.
You may also see sparsentan referred to as a “dual endothelin angiotensin II receptor antagonist” or DEARA. This refers to how sparsentan acts in the body: it blocks cells from making endothelin and angiotensin II.
Patients and families should follow the prescribing information and their healthcare provider’s instructions. Your kidney doctor will explain how this medication should be taken and monitored.
Understanding Your Condition
FSGS is a term that describes damage to the filtering units (called glomeruli) of the kidneys. It is diagnosed through a kidney biopsy, when a characteristic pattern of scarring is seen in the kidneys.
focal = some
segmental = parts of
glomerulo = kidney filters
sclerosis = are scarred
This scarring is permanent and can get worse over time. The damage from the scarring prevents those parts of the kidneys from working properly. This can cause protein to spill into the urine when it’s not supposed to, leading to even more damage.
There are four main types of FSGS disease:
- Primary FSGS develops on its own, with no known cause. It is believed to be related to an issue in the immune system.
- Secondary FSGS occurs due to an identifiable cause, such as a viral infection, medication toxicity, or another medical condition (like obesity or an unrelated autoimmune disease).
- GEFS genética is caused by a change in your genes. It can be inherited from family members or caused by a new gene mutation that was not passed down from either parent.
- FSGS of Unknown Cause develops from a cause not yet understood.
FSGS can affect both children and adults. It can also behave differently from person to person.
Because FSGS can present differently from one person to another, the most important step is to speak with your doctor about what treatment plan is right for you and your current condition.
Ask your doctor. You can ask for a copy of your kidney biopsy report and have your doctor explain what it shows.
You can also ask whether genetic testing may be right for you or your child. For some individuals, genetic testing may help explain the cause of FSGS and help guide care.
Nephrotic syndrome is not a disease. It is an umbrella term for a collection of medical signs that occur together. It describes a patient’s current condition and is characterized by the presence of three symptoms happening at the same time:
- proteinuria greater than 3.5 g/24h
- serum albumin less than 3.0 g/dL
- edema (swelling caused by excess fluid buildup)
Your doctor will look at your current physical condition, blood work, and urine samples to determine whether you currently have nephrotic syndrome.
No. While FSGS and nephrotic syndrome may be diagnosed together, they are not the same condition.
FSGS describes a type of damage seen in the kidney filters on a kidney biopsy.
Nephrotic syndrome can be a symptom of FSGS, or a sign of kidney damage, but not all patients with FSGS have nephrotic syndrome.
Many FSGS patients often transition in and out of nephrotic syndrome episodes, depending on how their kidney disease behaves or responds to treatment.
If you currently have nephrotic syndrome, you should continue working closely with your kidney doctor to determine the treatment plan that is right for you.
FSGS can change over time, and people may move in and out of nephrotic syndrome. If your condition changes and you no longer have nephrotic syndrome, your doctor can adjust your treatment plan to make sure it is right for you.
Regular check-ups are important, so your doctor can see how your condition is changing and help guide your care.
Nephrotic syndrome is not always permanent. It reflects how the disease is behaving at a specific moment in time.
Some patients may have nephrotic syndrome at one point in their journey and not at another. That is why doctors evaluate patients based on their current condition.
FSGS without nephrotic syndrome should still be treated as a serious condition.
Some patients who do not have nephrotic syndrome may feel relatively well, but even low levels of protein in the urine can still harm the kidneys over time. That is one reason lowering proteinuria is so important. If you are unsure, talk to your doctor and they can help guide you.
Potentially, yes.
The approved patient population includes all types of FSGS. Your doctor will need to evaluate whether you currently have nephrotic syndrome and what treatment plan is right for you.
Yes. Even if you do not have nephrotic syndrome, it is important to seek treatment. If you have protein in your urine, it means your kidneys are not working as they should. You may not feel sick or have swelling, but damage can still be happening over time.
That is why lowering protein in the urine is important. It can help protect your kidneys and may help slow down how quickly the disease gets worse. Your doctor can help you decide what treatment is right for you.
Not always. Some patients may need a kidney biopsy to confirm their diagnosis. But in certain cases, a genetic test may be enough. Your doctor will decide which test is right for you based on your condition and medical history.
Pediatric and Family FAQs
The FDA approves medicines based on the ages that were included in clinical studies.
At this time, there is not enough information from studies in children younger than 8 years old. Because of this, sparsentan is only approved for children 8 years of age and older.
Doctors and researchers continue to learn more about how to treat younger children with FSGS
For patients who are unable to swallow pills, sparsentan may be crushed and mixed in water right before giving the medication. Your kidney doctor and/or pharmacist will provide detailed instructions on how to properly crush and mix the pills.
Questions About Access
Sparsentan is available for nephrologists to immediately prescribe to individuals with FSGS.
The FDA requires patients taking sparsentan to follow a Risk Evaluation and Mitigation Strategy (REMS) Program to help you and your doctor monitor liver function. Your doctor will do blood tests to check your liver before starting treatment with sparsentan and every 3 months during treatment.
Travere offers Travere TotalCare, a patient support program that offers one-on-one assistance for those prescribed sparsentan, which may include treatment information, financial support, and medication delivery for eligible patients.
Once your doctor submits the prescription, a dedicated Nurse Educator will reach out to you and support you throughout your treatment journey.
Sparsentan was studied in the Phase 3 DUPLEX trial, the largest study in FSGS to date, which included 371 patients.
In this study, sparsentan was compared to irbesartan, a commonly used off-label treatment. Additionally, there are no FDA-approved medications for FSGS other than sparsentan. In patients who did not have nephrotic syndrome, sparsentan showed the strongest reduction of protein in the urine. At 108 weeks, protein in the urine was reduced by 48% with sparsentan compared to 27% with irbesartan. FSGS patients without nephrotic syndrome were the group in which results were most clear and supported FDA approval.
These results show that sparsentan can meaningfully lower protein in the urine, which is important for helping protect the kidneys over time.
This is an important milestone for the FSGS community. For the first time, there is an FDA-approved medicine specifically approved for this condition.
This approval also includes children 8 years of age and older, expanding treatment to a group that is often not included in clinical trials but were in the DUPLEX study. For many patients and families who have waited a long time, this is a potential new treatment option and a big step forward in FSGS care.
