New FDA Approval: Trutakna Offers a New Treatment Approach for Adults With IgA Nephropathy
The FDA has granted accelerated approval to Trutakna (atacicept-vymj) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. Learn about how it works, clinical trial findings, safety information, and what patients should know.
Introduction
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Trutakna (atacicept-vymj), a new therapy designed to reduce proteinuria in adults living with primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease worsening.
IgA nephropathy is a chronic immune-related kidney disorder that can gradually damage kidney function. The approval represents an important development because Trutakna targets two immune system proteins involved in the underlying disease process: B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
The therapy is designed to reduce abnormal immune activity that contributes to kidney inflammation and injury. However, because the approval was granted through the FDA’s accelerated approval pathway, additional studies are still required to confirm whether Trutakna can slow long-term kidney function decline.
Understanding IgA Nephropathy
IgA nephropathy is one of the most common forms of primary kidney disease worldwide. It occurs when abnormal immunoglobulin A (IgA) antibodies build up and form immune complexes that become trapped in the kidneys. These deposits can trigger inflammation, leading to gradual kidney damage.
Many people with IgA nephropathy may experience few symptoms in the early stages. Some patients may notice blood in the urine, increased protein levels in urine, swelling, or high blood pressure. Over time, the disease can progress and may result in chronic kidney disease or kidney failure.
Research suggests that a significant number of patients with IgAN may experience serious kidney complications within 10 to 20 years after diagnosis. For this reason, reducing proteinuria, which refers to excess protein leakage into urine, is considered an important treatment goal.
How Trutakna Works
Trutakna is a biologic therapy that works by blocking both BAFF and APRIL, two immune signaling proteins involved in activating B cells.
B cells are immune cells responsible for producing antibodies. In IgA nephropathy, abnormal B-cell activity can contribute to the production of harmful immune complexes containing galactose-deficient IgA1 (Gd-IgA1). These complexes can accumulate in kidney tissue and cause inflammation.
By targeting BAFF and APRIL, Trutakna aims to reduce the immune processes that contribute to IgAN progression.
The treatment is administered as a 150 mg injection under the skin once weekly. It is designed for self-administration using an autoinjector, allowing eligible patients to receive treatment at home.
Clinical Trial Results Behind FDA Approval
The FDA approval was supported by results from the Phase 3 ORIGIN 3 clinical trial, a global, randomized, double-blind, placebo-controlled study evaluating Trutakna in adults with IgA nephropathy.
In an interim analysis involving the first 203 participants, researchers evaluated changes in urine protein levels after 36 weeks of treatment.
Patients receiving Trutakna experienced:
- A 46% reduction in proteinuria from baseline
- A 42% greater reduction compared with placebo
- A statistically significant improvement compared with placebo treatment
Researchers also observed reductions in levels of galactose-deficient IgA1, an immune marker associated with IgA nephropathy.
While these findings show that Trutakna can reduce proteinuria, scientists are continuing to study whether the medicine can provide long-term protection against declining kidney function.
The ongoing ORIGIN 3 trial is evaluating kidney function outcomes, including changes measured by estimated glomerular filtration rate (eGFR).
Safety and Possible Side Effects
Like other medicines that affect the immune system, Trutakna may increase the risk of infections because it reduces certain immune responses.
In clinical studies, the most commonly reported side effects included:
- Infections
- Injection site reactions
- Upper respiratory tract infections
- Redness or irritation at the injection location
Patients receiving Trutakna should be monitored for signs of infection. Healthcare providers may delay treatment if a patient has an active infection.
Before starting therapy, doctors may review a patient’s vaccination history because immune-modifying medicines can affect responses to certain vaccines. Live vaccines are generally not recommended during treatment unless specifically advised by a healthcare professional.
What Accelerated Approval Means
The FDA’s accelerated approval program allows promising medicines to become available earlier when they address serious conditions and show meaningful effects on a specific measure that is likely to predict clinical benefit.
For Trutakna, approval was based on its ability to reduce proteinuria. However, it has not yet been proven that the treatment prevents long-term kidney failure or slows kidney function decline.
Continued approval may depend on results from additional confirmatory studies.
A New Option for People Living With IgA Nephropathy
For many years, treatment options for IgA nephropathy have focused mainly on controlling symptoms, reducing inflammation, managing blood pressure, and protecting kidney function.
The development of targeted immune therapies represents a shift toward addressing the biological mechanisms that contribute to disease progression.
Experts involved in IgAN research have highlighted the importance of new approaches because many patients remain at risk of serious kidney complications despite existing treatments.
Trutakna may provide another option for eligible adults with primary IgA nephropathy, but treatment decisions should be made carefully with a nephrologist who understands the patient’s individual health situation.
About Vera Therapeutics
Trutakna was developed by Vera Therapeutics, a biotechnology company focused on developing therapies for autoimmune diseases, including kidney-related conditions.
The company states that it is continuing research into conditions where targeting BAFF and APRIL pathways may provide additional medical benefits.
Conclusion
The FDA approval of Trutakna marks a significant development in the treatment landscape for adults with primary IgA nephropathy. By targeting BAFF and APRIL, the therapy introduces a new approach aimed at reducing immune-driven kidney damage.
Clinical trial results show promising reductions in proteinuria, an important indicator associated with kidney disease progression. However, further research is needed to determine whether Trutakna can provide long-term protection against kidney function decline.
Patients with IgA nephropathy should discuss treatment options, benefits, and potential risks with their healthcare provider before starting any new medication.
Sources
- Vera Therapeutics. Trutakna (atacicept-vymj) Prescribing Information. July 2026.
- Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. “The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies.” Frontiers in Nephrology. 2024.
- Pitcher D, Braddon F, Hendry B, et al. “Long-Term Outcomes in IgA Nephropathy.” Clinical Journal of the American Society of Nephrology. 2023;18(6):727-738.
- Lafayette R, Barbour SJ, Brenner RM, et al. “A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy.” New England Journal of Medicine. 2026;394(7):647-657.
- Kidney Disease: Improving Global Outcomes (KDIGO). Clinical Practice Guideline for Management of IgA Nephropathy and IgA Vasculitis. 2025.
Medical Disclaimer
This article is intended for educational and informational purposes only. It does not provide medical advice, diagnosis, or treatment recommendations. Medication decisions should always be made with a qualified healthcare professional. Individual results may vary, and patients should discuss the risks and benefits of Trutakna or any other treatment with their doctor.