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IgA nephropathy clinical trial developments

Overview

Recent clinical trial results have demonstrated progress in treating IgA nephropathy (IgAN) through different therapeutic approaches.

In the phase 3 RAINIER trial, the investigational dual inhibitor povetacicept showed a significant reduction in proteinuria. Interim results indicated that participants receiving 80 mg every four weeks achieved a 52.0% reduction in the 24-hour urine protein-to-creatinine ratio at week 36, compared to a 4.3% reduction in the placebo group. The study also noted a reduction in galactose-deficient IgA1 levels and the resolution of hematuria in 85% of applicable participants.

Separately, final 24-month results from Otsuka Pharmaceutical’s phase 3 Visionary study regarding sibeprenlimab reported a 97.1% reduction in the risk of composite renal outcomes, such as renal function decline or failure, compared to a placebo. This study is noted as the first phase 3 IgAN trial to meet the KDIGO 2025 therapeutic goal of slowing renal function decline to near-physiological levels.

Entities

American Society of Nephrology · Otsuka Pharmaceutical · The New England Journal of Medicine · New England Journal of Medicine · Emory University School of Medicine

Timeline

  1. [HEALTH] 5 sources
    Otsuka Pharmaceutical reports kidney function preservation in IgAN study

    Otsuka Pharmaceutical's phase 3 Visionary study shows sibeprenlimab reduces the risk of composite renal outcomes by 97.1% in adults with primary IgA nephropathy.

  2. [HEALTH] 3 sources
    Povetacicept shows significant proteinuria reduction in IgA nephropathy trial

    Phase 3 RAINIER trial interim data shows povetacicept reduced proteinuria by 52% in adults with IgA nephropathy at week 36, significantly outperforming the placebo group.

Sources

checkrare.com · consultantlive.com · forchecaudine.it · karitas.si · lsdmagazine.com · notiziedi.it · pharmacytimes.com · technoblitz.it · timelines.issarice.com