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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
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E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
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Abstract titles should be brief and reflect the content of the abstract.
Immunoglobulin A (IgA) nephropathy is a progressive immune–mediated kidney disease characterized by deposition of Gd-IgA1–containing immune complexes in the glomerular mesangium. Sibeprenlimab, a humanized IgG2 monoclonal antibody, selectively binds to and inhibits the cytokine APRIL (a proliferation-inducing ligand), a key driver of IgA nephropathy pathogenesis. The ongoing phase 3 VISIONARY trial (NCT05248646) evaluates the efficacy and safety of sibeprenlimab versus placebo in adults (aged ≥18 years) with IgA nephropathy. In the prespecified interim analysis evaluating the primary endpoint, sibeprenlimab resulted in a significant placebo-adjusted reduction in 24-hour urinary protein to creatinine ratio (uPCR-24h) of 51.2% (P<0.0001) after 9 months and a clinically meaningful reduction in first void spot uPCR of 54.9% (95% CI, 44.8%–63.2%) after 12 months of treatment. Here, we report the effect of sibeprenlimab on microscopic hematuria, a hallmark of active glomerular injury in IgA nephropathy.
VISIONARY is a randomized, multicenter, double-blind, placebo-controlled trial in patients with biopsy-confirmed IgA nephropathy. Eligible patients were randomized 1:1 to sibeprenlimab or placebo every 4 weeks for 100 weeks. In addition to the primary efficacy endpoint, safety (secondary endpoint) and change in hematuria over time (exploratory endpoint) were evaluated in the interim analysis. Safety analyses included all randomized patients who received at least one dose of sibeprenlimab at the time of interim analysis cutoff. Microscopic hematuria, quantified by automated microscopy of urinary sediment, was considered positive if the red blood cell (RBC) count was greater than 5 per high-power field (HPF) and was assessed in patients with at least one uPCR-24h measure at baseline. Kaplan-Meier methods estimated time to and probability of hematuria resolution (0-5/HPF) by 12 months.
Of the 320 patients randomized, 143 were positive (>5/HPF) for microscopic hematuria at baseline (sibeprenlimab: n=66/152; placebo: n=77/168); 51 patients were lacking the baseline urine RBC count data (sibeprenlimab: n=21; placebo: n=30). At week 48, 82.5% (n=33/40) of patients receiving sibeprenlimab were negative for microscopic hematuria (0-5/HPF) compared with 52.6% (n=51/97) of patients in the placebo group (Figure 1). Kaplan-Meier estimates showed that in patients with hematuria at baseline (>5/HPF), probability of achieving microscopic hematuria resolution (0-5/HPF) was greater with sibeprenlimab (90.9%, 95% CI 82.5%–96.3%) than placebo (68.1%, 95% CI 57.6%-78.2%) over 48 weeks; median time to resolution was 9 weeks (95% CI 8.0-16.1 weeks) in the sibeprenlimab group and 24 weeks (95% CI 8.1-32.0 weeks) with placebo (Figure 2). The safety profile was comparable between sibeprenlimab and placebo. No deaths were reported.
In this interim analysis, sibeprenlimab led to more resolution of microscopic hematuria than with placebo in patients with IgA nephropathy. These findings complement the robust proteinuria reductions observed with sibeprenlimab and provide evidence for its potential to target a key immune driver of kidney injury. VISIONARY is ongoing to evaluate the safety and efficacy of sibeprenlimab in preserving kidney function based on estimated glomerular filtration rate slope over a 24-month treatment period.
