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Final phase III analyses from the ORIGIN and VISIONARY trials found that atacicept and sibeprenlimab slowed the decline in kidney function among adults with IgA nephropathy compared with placebo. The findings address a condition of the drugs’ accelerated FDA approvals; the results have been submitted or will be submitted to the FDA to support traditional approval.
Two drugs for IgA nephropathy — atacicept and sibeprenlimab — slowed the decline in kidney function compared with placebo in final analyses of their phase III trials, according to results reported October 24 at the American Society of Nephrology Kidney Week meeting. The findings address a requirement attached to their accelerated FDA approvals and are intended to support traditional approval.
In the 431-person ORIGIN trial, participants received weekly injections of atacicept or placebo. At week 52, average eGFR — a measure of kidney filtration — changed by -0.11 mL/min/1.73 m² with atacicept and -5.69 with placebo. Through week 104, the annualized eGFR slope was -0.60 per year in the atacicept group and -5.60 per year in the placebo group, a difference of 5.00 mL/min/1.73 m² per year.
In ORIGIN, a composite measure of kidney-disease progression occurred in 5.1% of atacicept recipients and 17.8% of those receiving placebo through week 104. The researchers reported a 76% lower risk with atacicept. The composite included sustained losses in eGFR, very low eGFR, long-term dialysis, transplantation, or death. No atacicept recipients reached dialysis, received a transplant, or died during the reported period; seven placebo recipients experienced one of those outcomes.
The 510-person VISIONARY trial tested sibeprenlimab, given every four weeks, against placebo. Over 104 weeks, annualized eGFR slope was 0.3 mL/min/1.73 m² per year with sibeprenlimab and -4.2 with placebo, a difference of 4.5. A kidney endpoint event occurred in one participant receiving sibeprenlimab (0.4%) and 28 receiving placebo (11.2%). The trial authors reported a 97% lower risk of that endpoint with treatment. The endpoint included sustained creatinine doubling, a sustained 40% eGFR reduction, very low eGFR, or starting kidney-replacement therapy.
Both trials were published simultaneously in the New England Journal of Medicine. In ORIGIN, adverse events were reported in 74.8% of atacicept recipients and 78.0% of placebo recipients; serious adverse events occurred in 7.0% and 15.4%, respectively. In VISIONARY, researchers said the 24-month safety findings were consistent with the interim analysis; overall adverse events, including infections, were similar between groups, and no deaths occurred.
Evidence for Preserving Kidney Function
The results matter because accelerated approval for both medicines was based on interim evidence that they reduced proteinuria, or excess protein in urine. The final analyses tested whether that earlier signal was accompanied by slower loss of kidney function — a key measure of whether treatment may help delay progression of the disease.
Both trials found a substantial difference in eGFR trends between treatment and placebo over about two years. That does not establish how each patient will fare, or prove that the medicines prevent kidney failure over a lifetime. But the findings give regulators and clinicians longer-term kidney-function data beyond the proteinuria results used for accelerated approval.
At a press conference, VISIONARY investigator Dana V. Rizk said the 2025 KDIGO guidelines call for treatment to bring the rate of eGFR decline below 1 mL/min/1.73 m² per year, matching the normal physiological rate described in the guidelines. The trial’s average sibeprenlimab slope was 0.3, while the atacicept slope was -0.60. These are group averages from separate trials, not evidence that one drug is superior to the other: the studies had different designs and endpoints, and neither directly compared the drugs.
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Accelerated Approval Follow-Up Trials
IgA nephropathy is an immune-mediated kidney disease. Both drugs received accelerated FDA approval after interim trial findings showed reduced proteinuria. The approval pathway required further trial evidence addressing whether treatment slows kidney-function decline, which is what the final analyses reported.
Atacicept is a TACI-Fc fusion protein that targets BAFF and APRIL, two immune-signaling molecules. Sibeprenlimab is an antibody that selectively inhibits APRIL. The drugs therefore target related parts of the immune system but are not the same treatment. ORIGIN enrolled adults with biopsy-confirmed disease and used weekly atacicept injections; VISIONARY tested sibeprenlimab injections every four weeks.
The investigators presented the results at the American Society of Nephrology’s annual Kidney Week meeting on October 24, 2026. Jonathan Barratt of the University of Leicester presented ORIGIN findings, while Rizk of the University of Alabama at Birmingham and colleagues reported VISIONARY results.
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Limits of the Two-Year Findings
The reported analyses cover up to 104 weeks; they do not establish the drugs’ effects over longer periods or whether the observed differences will translate into fewer cases of kidney failure across a broader population. The composite outcomes were uncommon in the treatment groups, particularly in VISIONARY, so the event counts are small even though the reported differences were statistically significant.
The trials used different participant groups, dosing schedules, and definitions of kidney progression. Their results should not be treated as a head-to-head comparison. The source report also does not provide detailed subgroup results beyond stating that ORIGIN findings were consistent across prespecified groups.
FDA decisions on traditional approval are still pending. The available report does not specify when regulators will act, whether they will request further information, or what changes, if any, may be made to prescribing information. Trial findings describe outcomes in study participants and do not determine which treatment is appropriate for an individual patient.
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FDA Review and Continued Follow-Up
Investigators said ORIGIN findings will be submitted to the FDA to support full approval. Otsuka Pharmaceutical said the VISIONARY findings have been submitted for traditional approval. The next regulatory milestone is an FDA review of the submitted evidence; no decision date was provided in the source report.
Barratt also said participants assigned to placebo in ORIGIN were being moved onto atacicept. Longer-term follow-up and any FDA decisions will add information about continued safety and kidney outcomes. Until those developments are reported, the two-year trial results remain the main final efficacy evidence described here.
Key Questions
What did the final trials find?
Both trials found slower average decline in kidney function with active treatment than with placebo over approximately two years. ORIGIN tested atacicept; VISIONARY tested sibeprenlimab.
Does this mean either drug has full FDA approval?
No. The report says both drugs received accelerated FDA approval based on interim proteinuria findings. The final trial results have been submitted or are to be submitted to support traditional approval, but the source does not report an FDA decision.
Can the results show which drug works better?
No. Atacicept and sibeprenlimab were tested in separate trials with different designs and endpoints. The reported results do not constitute a direct comparison between the medicines.
How long were participants followed in these analyses?
The key results covered up to 104 weeks, or about two years. The report does not establish whether the differences continue over longer follow-up.
What happens next?
The FDA will review the trial evidence submitted to support traditional approval. No regulatory decision timetable was reported; ORIGIN participants assigned to placebo were also being moved to atacicept, according to investigator Jonathan Barratt.
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