Nephronpower iconNephronpowerSep 29, 2026

Topic Discussion: Galactose deficient(Gd)-IgA1 as a biomarker in IgA nephropathy after the recent RCTs

The recent wave of IgAN trials has reinforced galactose-deficient IgA1 (Gd-IgA1) as a mechanistic/pharmacodynamic biomarker, but not as a validated diagnostic or monitoring test. Nonetheless, KDIGO 2025 states that urine protein excretion remains the only validated early biomarker guiding clinical decisions, and full drug approval is conditioned on the 24-month eGFR slope rather than Gd-IgA1 change.

Topic Discussion: Galactose deficient(Gd)-IgA1 as a biomarker in IgA nephropathy after the recent RCTs
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The recent wave of IgAN trials has reinforced galactose-deficient IgA1 (Gd-IgA1) as a mechanistic/pharmacodynamic biomarker, but not as a validated diagnostic or monitoring test.

Agents targeting "hit 1" of the four-hit pathogenesis model consistently and rapidly lower serum Gd-IgA1: atacicept (ORIGIN 3), sibeprenlimab (VISIONARY/ENVISION), telitacicept, nefecon, and povetacicept...

Nonetheless, KDIGO 2025 states that urine protein excretion remains the only validated early biomarker guiding clinical decisions, and full drug approval is conditioned on the 24-month eGFR slope rather...

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The recent wave of IgAN trials has reinforced galactose-deficient IgA1 (Gd-IgA1) as a mechanistic/pharmacodynamic biomarker, but not as a validated diagnostic or monitoring test. Nonetheless, KDIGO 2025 states that urine protein excretion remains the only validated early biomarker guiding clinical decisions, and full drug approval is conditioned on the 24-month eGFR slope rather than Gd-IgA1 change. Outside trials, Gd-IgA1's diagnostic and prognostic performance is only moderate and confounded by assay heterogeneity (lectin vs....

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Agents targeting "hit 1" of the four-hit pathogenesis model consistently and rapidly lower serum Gd-IgA1: atacicept (ORIGIN 3), sibeprenlimab (VISIONARY/ENVISION), telitacicept, nefecon, and povetacicept all reduce circulating Gd-IgA1 alongside meaningful proteinuria reductions.

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