Sibeprenlimab Slows Kidney Function Decline in IgA Nephropathy: Study
Interim results from the VISIONARY trial suggest that sibeprenlimab-szsi significantly slows the progression of kidney function decline compared with placebo in patients with primary immunoglobulin A nephropathy (IgAN). The findings indicate that targeting the underlying disease process may help preserve renal function and potentially delay progression to kidney failure in patients with this chronic glomerular disease.
VOYXACT demonstrated an increase in mean change for the estimated glomerular filtration rate (eGFR) from baseline of +0.7 mL/min/1.73 m2 compared to a decline of -4.8 mL/min/1.73 m2 in the placebo-treated group, providing early evidence that sibeprenlimab may stabilize eGFR decline in patients with IgA nephropathy, which will be further validated in the ongoing Phase 3 VISIONARY trial. These results were presented at the European Renal Association (ERA) Congress 2026 in Glasgow as part of a pre-specified interim analysis of the VISIONARY Phase 3 trial. In the VISIONARY study, VOYXACT was well tolerated with a favorable safety profile in line with previously reported data. Full data from the VISIONARY study final analysis will be presented at a future medical conference. These findings provide clinical evidence linking upstream selective A-PRoliferation-Inducing Ligand (APRIL) inhibition to downstream preservation of kidney function, reinforcing VOYXACT’s ability to improve long-term outcomes.
“For patients with IgA nephropathy, slowing the loss of kidney function is essential to improve long-term outcomes, including the likelihood of kidney failure and the need for dialysis or transplant,” said Vlado Perkovic, MBBS, Ph.D., Provost at the University of New South Wales, Australia. “These data are very encouraging and suggest that selective inhibition of APRIL may slow eGFR decline, helping patients preserve kidney function and improve long-term outcomes.”
In this pre-specified interim analysis of the global VISIONARY Phase 3 trial (n=320; sibeprenlimab, n=152; placebo, n=168), patients treated with sibeprenlimab showed an increase in the mean eGFR change from baseline of +0.7 (95% CI, -0.9 to 2.3) mL/min/1.73 m² compared to a decline of -4.8 (95% CI, -6.3 to -3.3) mL/min/1.73 m² in the placebo-treated arm, representing a treatment effect of 5.5 (95% CI, 3.4 to 7.6) mL/min/1.73 m². At 12 months, sibeprenlimab showed a mean eGFR change from baseline that meets the KDIGO treatment goal to reduce the annual kidney function decline to the normal physiological rate of (<1 mL/min/1.73 m2/year).
Supporting the preservation of kidney function observed in the change from baseline analysis, the annualized slope of eGFR showed -3.0 (95% CI, -4.6 to -1.4) mL/min/1.73 m²/year with sibeprenlimab compared to -7.6 (95% CI, -9.1 to -6.1) mL/min/1.73 m²/year with placebo over 12 months, showing a treatment effect of 4.6 (95% CI, 2.5 to 6.8) mL/min/1.73 m²/year. The overall safety profile of VOYXACT was comparable to placebo, with infections and injection site reactions as the most common adverse events. Sibeprenlimab was generally well tolerated, and the types and frequencies of treatment-emergent adverse events (TEAEs) were comparable to placebo1.
“Together with previously observed reductions in Gd-IgA1, proteinuria, and hematuria, these new eGFR data show preserved kidney function over 12 months, which expand the growing body of evidence for VOYXACT demonstrating the potential to meaningfully improve clinical outcomes for adults with primary IgAN at risk for disease progression,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “These findings strengthen the rationale for selective APRIL inhibition as a targeted approach that modulates B-cell activity to reduce pathogenic IgA production, without B-cell depletion, differentiating selective APRIL inhibition as a safe and effective option for improving outcomes for patients with IgA nephropathy.”
