New England Journal of Medicine Publishes Complete Results of Positive Phase 2 Trial of Sibeprenlimab in Treatment of Immunoglobulin A Nephropathy (IgAN)
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- View the full release here: https://www.businesswire.com/news/home/20231102845310/en/
The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections of sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months. - The primary outcome measure was the change from baseline in 24-hour urine protein-to-creatinine ratio (uPCR) at month 12.
- The annual eGFR change was −2.7, +0.2, −1.5, and −7.4 ml/1.73 m2 with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively.
- This reflects a stabilization of eGFR with sibeprenlimab compared to the eGFR decline observed with placebo.1
The incidence of treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar.