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NephCure, a leading nonprofit organization fighting to ensure that all individuals with rare, protein-spilling kidney disease have equitable access to the care and treatments that offer them the best kidney health outcome possible, is proud to celebrate the third annual APOL1 Kidney Disease Awareness Day, on April 28, 2026. This day is dedicated to raising awareness of APOL1 kidney disease, which is a genetic form of kidney disease that disproportionately affects people of African ancestry. 

Apolipoprotein L1 (APOL1) kidney disease is caused by specific variants in the APOL1 gene that can led to an increased risk of developing kidney disease. These variants are believed to have originated in populations in West Africa, where they developed thousands of years ago as protection against certain parasitic diseases. 

APOL1 kidney disease disproportionately impacts individuals of African ancestry: 

• African Americans make up 13% of the U.S. population, but account for nearly 35% of people with kidney failure in the U.S. 
• 1 in 8 African Americans are at risk of a genetic form of kidney disease (caused by the APOL1 gene mutations). 
• APOL1 kidney disease is particularly aggressive and currently has no FDA-approved treatments. 
• Approximately 40% of African Americans on dialysis have kidney failure caused by APOL1. 

Because individuals who inherit certain APOL1 variants may face a higher risk of developing kidney disease, education, awareness, and advocacy are critical to enabling early detection, improving outcomes, and advancing equitable access to care. 

In honor of APOL1 Awareness Day, NephCure has launched a multi-channel awareness campaign designed to empower the nephrology community with accessible, up-to-date information on APOL1kidney disease. The initiative highlights critical resources, including genetic testing, care pathways, and emerging treatment options, to support informed decision-making and improved patient outcomes. 

Get Involved: 

NephCure invites everyone to spread awareness on social media by downloading the toolkit. The toolkit allows the public to share APOL1 kidney disease awareness graphics and patient stories on social media channels. 

For those living with APOL1 Kidney Disease, we encourage you to raise your voice and help drive meaningful change in access to care and treatment. By sharing your story, you can help drive progress in how this disease is understood and treated. This APOL1 Awareness Day, April 28, we’re unveiling a unique opportunity to connect directly with the researchers and decision-makers who are shaping the future of APOL1 care. Sign up to be the first to learn how you can get involved, haga clic aquí.  

To learn more about APOL1 Kidney Disease Awareness Day, and NephCure’s APOL1 awareness efforts, please visit NephCure.org/APOL1-Awareness-Day-2026 

About NephCure: 
NephCure’s mission is to ensure that all individuals with rare, protein-spilling kidney disease have equitable access to the care and treatments that offer them the best kidney health outcome possible. Founded in 2000 by a group of committed patient parents, NephCure has invested more than $40 million in kidney disease research and helped create a landscape where there are now new treatments and more than 60 interventional drug trials for rare kidney diseases. NephCure is a U.S. tax exempt 501(c)(3) public charity. 

FILADELFIA, PA – March 1,2026 – March is National Mes del Riñón, and NephCure is proud to join the global movement to raise awareness about kidney health. NephCure has been squarely focused on rare, protein-spilling kidney diseases (RKD) for the last twenty-six years and is committed to advocating for the many patients and families affected by conditions such as FSGS, IgAN, MN, and other rare, protein-spilling kidney diseases. 

NephCure Leverages Kidney Month Campaign to Support New Mission 

In January 2026, NephCure announced a new mission that reflects both the extraordinary progress achieved for rare kidney disease and the organization’s vision for the next era of patient support.  

For more than 25 years, NephCure has worked alongside patients, caregivers, researchers, physicians, and industry partners to transform the rare kidney disease landscape. When the organization was founded, scientific understanding of these conditions was limited, there were no FDA-approved treatments, and virtually no therapies in development to serve the hundreds of thousands of Americans affected by rare kidney diseases. 

Today, that landscape has dramatically changed. NephCure has helped make six FDA-approved treatments possible, supported more than 60 clinical trials, and built a thriving community of over 40,000 families. 

However, scientific progress alone is not enough. 

Too many families still face delayed diagnoses, limited access to specialists, and systemic barriers that prevent timely access to care and emerging treatments. In response, NephCure has refined its focus and introduced its new mission: 
 
To ensure that all individuals with rare, protein-spilling kidney disease have equitable access to the care and treatments that offer them the best kidney health outcome possible. 

Kidney Month Campaign Highlights 

NephCure’s Kidney Month campaign is composed of a dedicated Página de inicio del Mes del Riñón, email outreach and a social media campaign that not only explain their new mission but also demonstrates the meaningful steps already underway to bring that mission to life. 

The campaign includes: 

• Opportunities for patients to share their stories through written or video submissions
•  A social media advocacy toolkit encouraging supporters to share messages  on their own platforms 
• Inspiring Historias de pacientes offering guidance and connection 
• A community survey to better understand patient needs
• Information about and registration to Riñones raros en el día de la colina, an advocacy event that connects patients directly with Members of Congress to advance health equity through meaningful legislation  
• Brand education about NephCure, including the 2025 Impact Report detailing NephCure’s programs and research investments 
• Volunteer opportunities 
• A curated collection of educational tools designed to expand access to care 
• Kidney Month merchandise, including hats and pins that promote grassroots awareness 

NephCure invites individuals, organizations, and advocates to help amplify the voices of those living with rare kidney diseases. By raising awareness, we can accelerate progress toward better treatment access and improved quality of life for all who are affected. 

Show your support this Kidney Month by purchasing a Kidney Month pin and sharing your advocacy on social media using our downloadable toolkit by clicking aquí.  

Corporate Sponsors and Partners  

Thank you to our NephCure Corporate Members who are our valued partners for Kidney Month and World Kidney Day Campaigns. Their generous support enables NephCure to develop programs, events and educational resources to pursue our mission of ensuring access to the care and treatments that offer patients the best kidney health outcome possible.  

Thank you to: Travere Therapeutics, Boehringer-Ingelheim, Novartis, Otsuka, Vertex Pharmaceuticals, Apellis Pharmaceuticals, Alexion, Amicus Therapeutics, AstraZeneca, Calliditas Therapeutics, and Vera Therapeutics. 

Additionally, NephCure is partnering with Xtrema Ceramic Cookware, and PatientsLikeMe to amplify the Kidney Month campaign across social media.  

Acerca de NephCure 

NephCure’s mission is to ensure that all individuals with rare, protein-spilling kidney disease have equitable access to the care and treatments that offer them the best kidney health outcome possible. Founded in 2000 by a group of committed patient parents, NephCure has invested more than $40 million in kidney disease research and helped create a landscape where there are now new treatments and more than 60 interventional drug trials for rare kidney diseases. NephCure is a U.S. tax exempt 501(c)(3) public charity. 

Dear NephCure Rare Kidney Disease Community, 

As you may know, the U.S. Food and Drug Administration (FDA) has been reviewing an application for FILSPARI (esparsentán) para el tratamiento de glomeruloesclerosis focal y segmentaria (FSGS). The initial date for the FDA to make a decision on this drug was January 13, 2026. On that date, the FDA issued what is called a major amendment, which means the review process will take more time.

The information below is intended to clarify what this change to the FDA’s review timeline means, and just as importantly, what it does not mean.

What is a Major Amendment?
A major amendment is neither an approval nor a denial from the FDA. It means that the FDA now has more time to complete its review of the study data.

It means:

• The FDA is continuing its review of the drug and its study data.
• The FDA will be in contact with the study sponsor (Travere Therapeutics) and may ask for additional information or have further questions.
• The FDA issues a major amendment only when additional review time could potentially support an approval. It gives the FDA more time to fully evaluate the study data and review questions they have identified up to this point. 

A major amendment extends the Prescription Drug User Fee Act (PDUFA) decision date by three months. The new PDUFA  date for sparsentan in FSGS, or target date for the FDA to make their decision, is April 13, 2026.

The FDA may make a decision earlier than that date if they determine they have enough information to complete their review. 

You may be aware that sparsentan has already been approved by the FDA to treat IgA nephropathy (IgAN) in adults, which is another rare and progressive kidney disease that can be characterized by proteinuria. Although this means that the FDA is already familiar with sparsentan and its safety and efficacy in IgAN, it’s important to note that the approval of any drug for a distinct disease must be studied and reviewed separately. In other words, approval for IgAN does not automatically mean approval for FSGS.

What Does This Mean for You?
For individuals affected by FSGS, every step forward matters. This extension allows additional time for careful review of data and discussion around this condition – its high costs to individuals’ quality of life and overall health, future risks, and the current lack of treatments. NephCure remains optimistic about the path forward for sparsentan, and respects the FDA’s rigorous and careful review process, particularly for complex diseases like FSGS. 

At the same time, we understand that the added waiting period for this regulatory review can be difficult. Many in the FSGS community are living with uncertainty every day, and delays can feel deeply personal. We know that a great deal of disease progression can occur in a few short months for individuals living with FSGS. NephCure is committed to keeping the rare kidney disease community informed with clear updates, and we will continue to elevate the patient voice and keep the experiences, needs, and preferences of those living with FSGS at the forefront for decision-makers at the FDA.

Join the FSGS Community Town Hall
To help provide more details and answer your questions related to this update, NephCure will host a virtual FSGS Community Town Hall on Wednesday, January 21^calle at 7pm ET. 

El town hall will be led by NephCure Specialists Dr. Matthias Kretzler  and Howard Trachtman. 

It will focus on: 

• Sharing more information on the drug development and FDA review process
• Explaining how this may impact you and your family
• Listening to our FSGS community and answering your questions 
• Providing ways that you can make your voice heard by decision-makers

Anyone impacted by FSGS should join this important conversation. To view the FSGS Community Town Hall, haga clic aquí. 

Additional resources and updates will be shared in the coming weeks to ensure the RKD community stays informed.

Atentamente, 
Josh Tarnoff and the NephCure Team

December 2, 2025 — Last week, another major step forward was made for the IgA nephropathy (IgAN) comunidad. The FDA granted accelerated approval for VOYXACT (sibeprenlimab-szsi), Otsuka’s new treatment for adults with primary IgAN who are at risk for disease progression. 

The FDA’s accelerated approval program allows for earlier access to treatments that address serious conditions with unmet medical needs by using a surrogate endpoint. Defined by the FDA, a surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives. In this case, the surrogate endpoint is proteinuria reduction. 

IgAN is a kidney disease in which Immunoglobulin A (IgA) builds up in the kidney. IgA is a protein in the blood and is also part of the immune system. Excess IgA can cause inflammation in the kidney and over time, this leads to scarring in the kidney tissue. The severity of kidney disease caused by IgAN varies from person to person. As IgAN progresses, it reduces the kidneys’ ability to filter waste from the blood.

While VOYXACT is not the first treatment approved for IgAN, it is the first therapy that blocks a molecule called A-PRoliferation-Inducing-Ligand (APRIL). APRIL plays a role in creating harmful IgA that drives the disease process. By blocking APRIL, VOYXACT reduces levels of galactose-deficient IgA1 (Gd-IgA1), the form of IgA closely linked to IgAN.

The FDA’s approval for VOYXACT was granted based on interim data from Otsuka’s Phase 3 VISIONARY study, which showed:

• A 51% placebo-adjusted reduction in proteinuria at 9 months
  • Patients on VOYXACT saw a 50% decrease in proteinuria compared to a 2% decrease in the placebo group.
• Reductions were seen at 9 months of treatment among 320 participants.

Proteinuria is a widely accepted indicator of kidney health in IgAN. Lowering proteinuria is associated with slowing damage to the kidneys, which is why it is used as a surrogate marker for accelerated approval.

It is not yet known whether VOYXACT slows long-term kidney function decline. The ongoing Phase 3 VISIONARY study will evaluate this, with results expected in 2026.

With this latest approval, there are now six FDA-approved Opciones de tratamiento for rare kidney disease:

• VOYXACT (sibeprenlimab-szsi) – Approved for IgAN
• EMPAVELI (pegcetacoplan) – Approved for C3G and primary IC-MPGN
• FABHALTA (iptacopan) – Approved for C3G and IgAN
• FILSPARI (sparsentan) – Approved for IgAN
• TARPEYO (budesonide) – Approved for IgAN
• VANRAFIA (atrasentan) – Approved for IgAN

If you or a loved one has IgAN, talk with your nephrologist to determine whether VOYXACT or another treatment option may be right for you.

To read Otsuka’s full press release about the FDA approval of VOYXACT, click aquí.

For more information about IgA nephropathy or to explore NephCure’s educational resources, haga clic aquí.