Trutakna Demonstrates Sustained Kidney Function Preservation in IgA Nephropathy Over Two Years

Adults with IgA nephropathy treated with Trutakna (atacicept-vymj) experienced an average annual decline in estimated kidney function of just 0.6 units over two years, compared with a 5.6-unit decline in the placebo group, Vera Therapeutics announced on September 15. The findings stem from the final efficacy analysis of the 428-patient ORIGIN 3 trial.

Estimated glomerular filtration rate (eGFR)—a blood-test measure of how efficiently the kidneys filter waste, expressed in mL/min/1.73m²—serves as a direct gauge of kidney function. Trutakna’s accelerated approval in July was based on reduction of protein in the urine, a surrogate marker; at the time, the FDA noted it had not been established whether the drug slows long-term kidney function decline. The new eGFR data begin to address that gap, though the results remain company-reported and have not yet undergone FDA review.

The implications are significant for patients typically diagnosed in their 30s and 40s, for whom slowing kidney loss could preserve function across decades of life.

Two-Year Kidney Outcomes in the ORIGIN 3 Trial

At one year, eGFR in the Trutakna arm was essentially stable, declining by an average of 0.1 units versus a 5.7-unit drop on placebo. Over the full two-year period, the annualized rate of decline was 0.6 units with Trutakna versus 5.6 units with placebo—a difference of 5.0 units per year.

Kidney disease progression events occurred in 11 Trutakna recipients and 38 placebo recipients, corresponding to a 76% lower risk, though the composite endpoint was not fully defined in the announcement. No patient on Trutakna required dialysis for 30 days or more, received a transplant, or died during the study period, compared with eight such events in the placebo group.

Vera noted that the observed eGFR trajectory aligns with international guideline targets of slowing decline to less than 1 unit per year, a rate approximating normal aging. Trutakna also reduced proteinuria, hematuria, and levels of galactose-deficient IgA1, an aberrant antibody implicated in the disease. Overall adverse event and infection rates were similar between arms, and no opportunistic infections were reported.

“Prevention of kidney failure or kidney-related death is the ultimate goal,” said Richard Lafayette, MD, director of the Glomerular Disease Center at Stanford University Medical Center and a principal investigator in the company-sponsored trial (ClinicalTrials.gov registration).

Context from the July Approval and Outstanding Questions

Since the FDA’s July approval—granted on the basis of a 46% average reduction in proteinuria at nine months in the first 203 patients—the evidentiary gap has narrowed. Vera reached an agreement with the FDA in June to advance the eGFR analysis, according to AJMC. The newly released topline data represent the confirmatory evidence regulators sought, though detailed results are slated for presentation at an upcoming scientific meeting.

ORIGIN 3 is a randomized, double-blind, placebo-controlled Phase 3 trial funded by Vera. The two-year findings have not been peer-reviewed, the FDA has not evaluated them, and the prescribing label remains unchanged. While two years of near-stable eGFR is encouraging, it does not constitute proof that patients will avoid kidney failure over a lifetime, particularly given the small number of hard clinical endpoints (dialysis, transplant, death) observed.

Trutakna is indicated for adults with primary IgA nephropathy at risk of disease progression. Safety and efficacy have not been established in pediatric patients, and pregnancy data are limited. Because the drug suppresses the immune system, patients with chronic or recurrent infections may face an elevated risk of serious infection; live vaccines are contraindicated within 30 days before and during treatment.

Coverage, Costs, and Discussion Points for Patients

The emerging data may influence both treatment decisions and household budgets. AJMC reported that payers are expected to adjust coverage policies and prior-authorization criteria as confirmatory evidence matures. Vera stated it received more than 350 patient start forms in the drug’s first 10 weeks on the market and is processing paid insurance claims.

The company’s TRU SUPPORT program provides insurance navigation and financial assistance; eligible commercially insured patients may pay as little as $0 out of pocket. Patients should verify eligibility directly, as terms vary by plan.

Key questions for a nephrologist include: how eGFR and proteinuria have trended over time, whether a biopsy confirmed the diagnosis, and whether the patient matches the at-risk population studied. Maintaining copies of recent lab results can facilitate insurance appeals. Vaccination status should be reviewed before initiating therapy.

Patients on Trutakna should promptly report fever, persistent cough, or other signs of infection. Injection-site reactions occurred in 30% of treated patients versus 5% on placebo in clinical trials. Difficulty breathing, facial swelling, or high fever warrants urgent medical attention. Concomitant blood pressure medications and other prescribed kidney therapies should not be discontinued without medical guidance.

Vera plans to submit a supplemental application for full approval in the fourth quarter of 2026, targeting a decision in 2027. Separately, the FDA is scheduled to rule on Vertex’s povetacicept, a mechanistically similar agent, by November 30, 2026.

The latest data suggest Trutakna can maintain kidney function near baseline for two years in at-risk adults. For younger patients facing decades with the disease, the stakes are especially high; the FDA’s forthcoming review of the complete dataset will determine whether the evidence supports broader, long-term confidence.

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