Adults with IgA nephropathy who took Trutakna (atacicept-vymj) lost an average of 0.6 units of estimated kidney function per year over two years, while those on placebo lost 5.6 units per year, Vera Therapeutics reported on Sept. 15. The results come from the final efficacy analysis of the 428-patient ORIGIN 3 trial.
Update Note: This article reports new two-year kidney function results for Trutakna following MedicalDaily's earlier coverage of the drug's July approval. The latest verified information comes from a Vera Therapeutics announcement dated Sept. 15, 2026, and reflects topline data from the ORIGIN 3 final efficacy analysis.
The measure behind this update matters. Estimated glomerular filtration rate, or eGFR, is a blood test estimate of how well the kidneys filter waste, measured in units of mL/min/1.73m², which makes it a direct gauge of kidney function. Trutakna's July accelerated approval rested on a different marker, protein in the urine, and the FDA's approval announcement stated, "It has not been established whether Trutakna slows kidney function decline over the long-term in patients with IgA nephropathy."
For families, the stakes are concrete. Vera says IgA nephropathy is most often diagnosed between ages 30 and 40, so slowing kidney loss could affect decades of a patient's life. The new data point is in that direction, but they are company-reported and has not yet been reviewed by the FDA.
Two-Year Kidney Results in the ORIGIN 3 Trial
At one year, kidney function in Trutakna patients was essentially unchanged, with an average eGFR change of minus 0.1 units, compared with minus 5.7 units on placebo. Over two years, the yearly rate of decline was 0.6 units on Trutakna versus 5.6 units on placebo, a difference of 5.0 units per year.
Eleven Trutakna patients and 38 placebo patients had a kidney disease progression event, which corresponds to a 76% lower risk, although the announcement did not fully define that combined measure. No Trutakna patient needed dialysis for 30 days or more, received a transplant, or died during the two years, compared with eight placebo patients.
Vera said the eGFR results align with an international guideline goal of slowing decline to less than 1 unit per year, close to the rate seen with normal aging. Trutakna also lowered urine protein, blood in the urine, and an abnormal form of an antibody linked to the disease. Rates of overall side effects and infections were similar between groups, 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. Lafayette is a principal investigator in the company-funded trial, which is registered on ClinicalTrials.gov.
Background from the July Approval and What Remains Unproven
MedicalDaily previously reported that the FDA approved Trutakna based on reductions in urine protein on July 7, after a 46% average drop in the first 203 patients at nine months, and that long-term kidney protection had not been shown. That report focused on a quickly expanding set of treatment options and on what the approval did not prove.
Since then, the evidence gap has narrowed. Vera reached an agreement with the FDA in June to move the eGFR analysis earlier, according to AJMC. The new data are the kind of confirmatory evidence regulators asked for, but they arrive as a topline announcement, and detailed results are promised at an upcoming scientific meeting.
In evidence terms, 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 drug's label has not changed. Two years of stable eGFR is encouraging, but it is not proof that patients will avoid kidney failure over a lifetime, and the number of dialysis, transplant, or death events was small.
The drug is approved for adults with primary IgA nephropathy at risk of disease progression. Its safety and effectiveness have not been established in children, and data in pregnancy are limited. Because Trutakna suppresses the immune system, people with chronic or recurring infections may face a higher risk of serious infection, and live vaccines are not recommended within 30 days before starting or during treatment.
Coverage, Costs, and Questions to Bring to a Nephrologist
The update could affect household budgets as much as treatment plans. When the drug was approved, AJMC noted that payers should expect coverage policies and prior authorization criteria to change as confirmatory data mature. Vera said it received more than 350 patient start forms in the drug's first 10 weeks on the market and is seeing paid insurance claims.
The company's TRU SUPPORT program offers insurance help and financial assistance, and eligible commercially insured patients may pay as little as $0 out of pocket. Patients should confirm eligibility directly, since terms vary by type of coverage.
Patients can ask their nephrologist how their eGFR and urine protein have changed over time, whether a biopsy confirmed the diagnosis, and whether they fit the at-risk group studied. Keeping copies of recent lab results can help with insurance appeals. Vaccinations should be reviewed before treatment starts.
People taking Trutakna should report fever, a persistent cough, or other signs of infection. Reactions at the injection site were common, affecting 30% of treated patients versus 5% on placebo in clinical trials. Trouble breathing, facial swelling, or a high fever warrants urgent care. No one should stop blood pressure medicines or other prescribed kidney treatments without medical advice.
Vera plans to file for full approval in the fourth quarter of 2026 and hopes for a decision in 2027. Separately, the FDA is due to rule on Vertex's povetacicept, another drug that blocks the same immune signals, by Nov. 30, 2026.
The newest data suggest Trutakna can keep kidney function close to steady for two years in at-risk adults. Young adults facing decades with this disease have the most at stake, and the FDA's review of the full results will determine whether the evidence holds up.
Key Questions Answered
What is new about Trutakna? Two-year results from the ORIGIN 3 trial show kidney function declined 0.6 units per year on Trutakna, compared with 5.6 units per year on placebo.
Why does eGFR matter more than urine protein? eGFR estimates how well the kidneys filter blood, so it measures kidney function directly. Urine protein, the basis for the July approval, is an indirect marker.
Does this prove Trutakna prevents kidney failure? Not yet. The data are company-reported, have not been peer-reviewed or evaluated by the FDA, and cover two years rather than a lifetime.
Who is Trutakna approved for? Adults with primary IgA nephropathy at risk of disease progression. Its safety and effectiveness have not been established in children.
What are the main side effects? Infections and injection-site reactions were the most common. Because the drug suppresses the immune system, patients should be checked for active infection before starting and should avoid live vaccines during treatment.
Will insurance cover it? Coverage varies by plan, and prior authorization is common. Vera offers a support program, and eligible commercially insured patients may pay as little as $0.
What happens next? Vera plans to seek full FDA approval in the fourth quarter of 2026, and the FDA is due to decide on the rival drug povetacicept by Nov. 30, 2026.
