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TRUTAKNA® (Atacicept)
Trutakna received accelerated FDA approval for treatment of IgAN (IgA Nephropathy) in July 2026. Trutakna reduces protein in urine in adults with IgAN.
Accelerated approval means that shorter studies showed Trutakna lowered proteinuria. This is a sign that in the long term, Trutakna may also help to slow loss of kidney function. The FDA made the medication available to patients while a longer study continues to test whether Trutakna slows loss of kidney function by measuring changes in eGFR.
Medically reviewed by Dr. Tripti Singh, MD
How does Atacicept (TRUTAKNA) work?
Trutakna is the first medicine that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL). BAFF and APRIL are required for survival and maturation of immune cells specifically B-lymphocytes and plasma cells. Trutakna decreases production of abnormal IgA antibody and decrease the damage to the kidneys leading to decreased protein in urine.
Trutakna is the first medicine that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL).
How is Atacicept (TRUTAKNA) administered?
It is given as a weekly under the skin (subcutaneous) injection. The device to inject the medication is called autoinjector, that is pre-filled, single use and disposable. (This means you will not need to fill a syringe yourself and there is only one click to take the injection under your skin.)
The injection is usually given in stomach (abdomen) or thighs. Your healthcare provider team will train you (or a caregiver) on how to prepare and give injections at home.
Is Atacicept (TRUTAKNA) right for me?
You and your doctor should decide together whether Trutakna is right for you. If you have IgA Nephropathy and protein in urine, you should discuss with your kidney doctor if you should consider this medication for treatment of your kidney disease. In patients with IgAN who have significant protein in urine, this medication can decrease protein in urine. In IgAN patients, lower amount of protein in urine is associated with decreased chances of progression to kidney failure. Thus, decreasing protein in urine is one of the major treatment goals in IgAN.
*Nota: La decisión de recetar un medicamento es responsabilidad de su médico/proveedor de atención primaria según la evaluación de su afección. Lo anterior está destinado únicamente a fines informativos. Discuta esta información y toda la información sobre drogas/medicamentos con su médico antes de comenzar o suspender cualquier medicamento.
Preguntas frecuentes
Trutakna has received accelerated approval for treatment of IgAN in adults. This approval is based on Phase 3 randomized clinical trial (the ORIGIN trial).
In this trial 203 patients with IgAN and eGFR of 65 ml/min/1.73m2 and 1.7 gms of protein in urine were treated with Trutakna (atacicept) and renin angiotensin system inhibitor (RASi) and sodium glucose co-transporter inhibitor (SGLT2i). Another group of patients was treated with placebo (inactive injection), RASi and SGLT2i. The two groups were then compared.
Patients with IgAN treated with Trutakna, RASi and SGLT2i achieved a significant 46% reduction in proteinuria from baseline at week 36 compared to IgAN patients on placebo, RASi and SGLT2i.
It has not been established whether Trutakna slows kidney function decline over long term in patients with IgAN. The ORIGIN clinical trial is ongoing to confirm that Trutakna slows kidney function decline over long-term in patients with IgAN by measuring changes in eGFR.
Atacicept is the first medication in the group of medications that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL).
One of the other medications that is FDA approved for treatment of IgAN is Voyxact (sibeprenlimab) that targets only A Proliferation Inducing Ligand (APRIL), while acacicept targets both BAFF and APRIL.
Both atacicept and sibeprenlimab decrease abnormal IgA levels in blood and decrease protein in urine.
Iptacopan (Fabhalta) is also FDA approved for treatment of IgAN. Iptacopan blocks part of the complement system, which is part of the immune system. When the abnormal IgA in the blood deposits in the kidneys, it activates the complement system. This leads to scarring and kidney damage. Iptacopan helps to stop this activation and the damage it causes to the kidney filters.
Tarpeyo (delayed release budesonide) is also FDA approved for treatment of IgAN. Tarpeyo decreases the production of abnormal IgA in the intestines. Less abnormal IgA then deposits in the kidneys.
Filspari (sparsentan) y Vanrafia (atresentan) are also FDA approved for treatment of IgAN. These two medications however do not work on the immune system but decrease in protein in urine by blocking endothelin receptor and decrease scarring in the kidney due to damage caused of abnormal IgA immune complex.
Atacicept was well tolerated by IgAN patients in the clinical trial. Total adverse events were similar in atacicept and placebo treated groups except more injection site reactions with atacicept. Since atacicept blocks components of immune system, there is increased risk of infections with this class of medications called immunosuppressants. However, in the clinical trial, the rate of infections were similar in atacicept group when compared to placebo group.
There are 2 broad categories of medications that are used to treat IgAN, immunosuppressants that block different parts of the immune system and medications that decrease the ongoing damage due to previous injury caused by IgAN.
Atacicept belongs to the first category of medications called immunosuppressants. There are 3 other FDA approved immunosuppressants for treatment of IgAN.
Note: we can hyperlink these to the full articles already posted on the treatment page so patients can click for more detailed information.
- Voyxact (Sibeprenlimab) that targets A Proliferation Inducing Ligand (APRIL) and decrease abnormal IgA levels in blood and decrease protein in urine.
- Iptacopan (Fabhalta) that blocks complement system that causes damage to the kidney and is activated by abnormal IgA immune complex molecules in the blood.
- Tarpeyo (delayed release budesonide) decreases the production of abnormal IgA in the intestines.
- Oral steroids like prednisona are another immunosuppressant that have been shown in clinical trials to decrease protein in urine and protect the kidneys. However, oral steroids have a lot of side effects like weight gain, anxiety, diabetes, acne, trouble sleeping etc.
The medications the decrease the ongoing damage due to already occurred injury by IgAN include:
- renin angiotensin system inhibitor (RASi)
- sodium glucose co-transporter inhibitor (SGLT2i)
- Dual Endothelin Angiotensin Receptor Antagonist (DEARA)
- Endothelin Receptor Antagonist (ERA)
RASi and SGLT2i work for all kidney diseases with protein in urine including IgAN.
DEARA and ERA have been specifically studied in IgAN to decrease protein in urine and slow the progression of kidney disease.
Atacicept is FDA-approved for the treatment of IgAN and therefore should be covered by most insurance plans. There are other financial support options that also may be available through the drug company that can help with medication costs. You should talk to your kidney doctor and treatment team if you should be treated with atacicept.
*Nota: La decisión de recetar un medicamento es responsabilidad de su médico/proveedor de atención primaria según la evaluación de su afección. Lo anterior está destinado únicamente a fines informativos. Discuta esta información y toda la información sobre drogas/medicamentos con su médico antes de comenzar o suspender cualquier medicamento.
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