Clinical Study

Otsuka Sibeprenlimab Injections For Iga Nephropathy

Posted Date: Aug 2, 2023

  • Investigator: Ahmad Anjak
  • Specialties: Kidney Disease, Nephrology
  • Type of Study: Drug

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN. Up to 470 subjects will be enrolled from up to 300 global sites in approximately 32 countries, and randomized (1:1) to sibeprenlimab or placebo administered as a SC injection once every 4 weeks. APRIL, a member of the tumor necrosis factor ligand superfamily, has emerged as a key factor in the pathogenesis of IgAN through its mediation of Ig isotype switching during B-cell development, production of IgA, plasma-cell survival, and potentially the production of galactose-deficient immunoglobulin A1 (g-d IgA1). These g-d IgA1 act as autoantigens and lead to development of autoantibodies which together form circulating immune complexes that subsequently deposit in the mesangium of glomeruli and trigger an inflammatory response and complement activation. Trials in subjects with IgAN have shown that elevated APRIL levels correlate with poor kidney outcomes, when compared with subjects with lower APRIL levels. A similar trend is also seen with g-d IgA1 levels, with higher levels associated with faster and more frequent progression to kidney failure when compared to patients with lower g-d IgA1 levels. The therapeutic goal of sibeprenlimab in IgAN is to reduce proteinuria and the decline of estimated glomerular filtration rate (eGFR). Sibeprenlimab binds to and blocks the biological actions of APRIL. Blocking APRIL reduces the production of IgA and g-d IgA1, thereby diminishing the formation of circulating immune complexes and their deposition in the glomeruli.

Criteria:

Biopsy-Proven Iga Nephropathy, On Stable Dose Acei Or Arb Upcr >0.75, Egfr >30 Subjects Of Childbearing Potential Or Men Able To Father Children Must Agree To Using Effective Birth Control. Exclusions Are: Secondary Iga, Diabetes Type 1, Nephrotic Syndrome, Transplant Or Current Steroid Use

Keywords:

Kidney, Iga, Proteinuria

For More Information:

Ahmad Anjak
513-558-3471
ahmad.anjak@uc.edu


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