Three drugs show sustained kidney function benefits in IgA nephropathy trials at 2 years

At Kidney Week 2026, final 2-year phase 3 trial results demonstrated that APRIL-inhibiting drugs—atacicept, sibeprenlimab, and telitacicept—significantly slowed kidney function decline in IgA nephropathy patients. In the ORIGIN and VISIONARY trials, atacicept and sibeprenlimab preserved eGFR rates below the 1 mL/min/1.73 m² annual KDIGO threshold and reduced composite kidney progression risks by 76% and 97%, respectively, prompting submissions for full FDA approval.

APRIL inhibitor trial results

• ▪The phase 3 TELIGAN trial evaluated 318 IgA nephropathy patients in China randomized to weekly subcutaneous telitacicept 240 mg or placebo through week 39, followed by biweekly maintenance
• ▪Phase 3 trial results presented at Kidney Week 2026 demonstrated that three APRIL-inhibiting drugs—atacicept, telitacicept, and sibeprenlimab—stabilized kidney function and slowed disease progression in patients with IgA nephropathy
• ▪The phase 3 VISIONARY trial evaluated 510 adult IgA nephropathy patients randomized to receive subcutaneous sibeprenlimab 400 mg or placebo every 4 weeks
• ▪The phase 3 ORIGIN trial evaluated adult patients with biopsy-confirmed IgA nephropathy randomized to receive weekly subcutaneous atacicept 150 mg or placebo

IgA nephropathy disease burden

• ▪Standard therapies for IgA nephropathy achieve 25% to 30% reductions in disease progression compared to higher reductions seen with APRIL-inhibiting B-cell modulating therapies
• ▪Immunoglobulin A (IgA) nephropathy is the most common primary glomerular disease and is typically diagnosed in young adulthood with a high risk of progressing to kidney failure
• ▪Standard IgA nephropathy treatments including SGLT2 inhibitors and renin-angiotensin-aldosterone system inhibitors slow disease progression but commonly fail to prevent progression to kidney failure

eGFR preservation outcomes

• ▪The 2025 KDIGO guidelines set an IgA nephropathy eGFR preservation target rate of decline below 1 mL/min/1.73 m² per year to match the physiological rate of healthy individuals
• ▪Over 104 weeks in the VISIONARY trial, sibeprenlimab achieved an annualized eGFR slope of 0.3 mL/min/1.73 m² per year compared to -4.2 mL/min/1.73 m² per year for placebo (P < .0001)

Composite kidney progression endpoints

• ▪In the ORIGIN trial, zero patients receiving atacicept progressed to dialysis, kidney transplantation, or death through week 104, compared with seven patients in the placebo group
• ▪In the VISIONARY trial, sibeprenlimab reduced the 24-month risk of composite kidney outcome events by 97.1% compared to placebo (HR 0.029, P < .001)
• ▪In the ORIGIN trial, atacicept reduced the 104-week risk of composite kidney disease progression by 76% compared to placebo (HR 0.24, P < .001)

FDA accelerated approval pathway

• ▪Atacicept and sibeprenlimab previously received accelerated FDA approval for IgA nephropathy based on interim trial analyses demonstrating significant reductions in proteinuria
• ▪Manufacturers Otsuka Pharmaceutical and Vera Therapeutics submitted final 24-month phase 3 trial efficacy data to the FDA to support full traditional approvals for sibeprenlimab and atacicept