Immunoglobulin A nephropathy (IgAN), also known as Berger’s disease, is a condition caused by the body’s immune system that affects the kidneys. Immunoglobulin A (IgA) is an antibody, which is a protein made by your immune system. In people with IgAN, IgA antibodies stick together and build up in your kidneys, causing inflammation and kidney damage. Some people with IgAN have no symptoms, while others have symptoms such as blood in their urine.
IgAN is a progressive disease, meaning it gets worse over time. There is no cure for IgAN, but certain treatments can slow down kidney damage. Trutakna (atacicept-vymj) is a new treatment option for IgAN. Trutakna is a prescription medicine approved in 2026 by the FDA to help people with IgAN lower the amount of protein in their urine (proteinuria) and prevent the condition from getting worse (progression).
How Does Trutakna Work for IgAN?
Trutakna blocks two proteins: B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By blocking APRIL and BAFF’s signals, Trutakna lowers the amount of abnormal IgA antibodies. This may help lower the immune activity that leads to kidney damage in people with IgAN.
How do I Use Trutakna?
Trutakna is given as a subcutaneous injection under the skin once a week.
Trutakna is available as a prefilled syringe called an autoinjector, which contains a single dose of medicine. You should take it out of the refrigerator and keep it at room temperature for 15-30 minutes before using it.
You can inject Trutakna into the stomach area (abdomen) at least 2 inches away from the belly button area. It can also be injected into the front of the upper legs (thighs).
Do not inject Trutakna into the same spot as your previous injection. You should also avoid injecting into moles, tattoos, cuts, or scratches, and areas that are irritated, bruised, red, sore, hard, or scarred.
Follow the guide that comes with your medicine. Ask your health care provider if you have questions about how to inject Trutakna.
How was Trutakna Studied for IgAN?
Trutakna was studied in a clinical trial called the ORIGIN 3 trial. The people in this study were treated with either Trutakna 150 milligrams (mg) or a placebo injection once weekly for at least 36 weeks. Placebo injections do not have any active medicine.
To qualify for the study, participants had to:
- Have IgAN that was confirmed by biopsy and protein in their urine
- Have kidney function above a certain level (an estimated glomerular filtration rate [eGFR] of ≥ 30 mL/min/1.73 m2)
- Be taking a kidney-protective medicine, such as an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a consistent dose for at least 12 weeks
have a blood pressure of 150/90 mmHg or lower.
If participants were taking a medicine in the sodium-glucose co-transporter 2 (SGLT2) inhibitor class, they had to have been receiving a stable dose for 12 weeks and stay on that dose during the study.
A total of 203 adults with IgAN participated in this study. At the start of the study:
- The average age of participants was 40-41 years.
- About 46% were female, and 54% were male.
- About 54%-56% were Asian, 43% were White, 6%-13% were Hispanic or Latino, and about 1% were classified as Other.
- About 51%-56% were taking an SGLT2 inhibitor.
- About 99%-00% were taking an ACEI or an ARB medicine.
What Are the Benefits of Trutakna Based on the ORIGIN 3 Study?
To see if Trutakna worked, the researchers looked at the amount of protein in the urine. After 36 weeks of taking the medicine, people who received Trutakna had about 42% less protein in their urine than those who took the placebo.
To see if Trutakna was safe, the researchers collected information on what types of side effects people experienced during the study. Side effects were reported in about 59% of participants treated with Trutakna and about 50% of participants treated with the placebo injection. The adverse events were generally mild to moderate in severity. They included injection-site reactions and redness at the injection site, upper respiratory tract infection, and inflammation of the nose and throat, known as nasopharyngitis.
Keep in mind that your results may be different than those seen in this study.
How Long Until I See the Full Effects of Trutakna?
This medicine works by slowing kidney damage, but it will not cure IgAN. You may start to see improvements in the amount of protein in your urine within the first few months, but it may take several months to see the full effects.
Keep in mind that your results may be different than what was seen in this study.
What Are Other Unique Considerations to Be Aware of?
Trutakna received accelerated approval from the FDA because studies showed that it reduced the amount of protein in the urine. But it is not yet known whether Trutakna slows kidney damage over the long term. The FDA may require more studies to confirm long-term benefits. Continued approval of Trutakna may depend on the results of those studies.
What Do I Need to Do to Get Trutakna and What Kind of Doctor Prescribes It?
If you have IgA nephropathy, your regular health care provider may refer you to a nephrologist, a specialist who treats people with kidney problems.
Trutakna is only available through a specialty pharmacy. Your doctor will order Trutakna directly through the specialty pharmacy, and it will be shipped directly to you.
Is There Any Cost Assistance Available for Trutakna?
Yes. The drugmaker of Trutakna offers a cost savings and support program that can help lower the cost for you. You may have options even if you do not have health insurance. Trutakna Tru Support is a service that offers insurance coverage support, financial assistance resources, and nurse educator help. Your health care provider can help you get started. You can also find more information about this program on the Trutakna Tru Support website.