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Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy.

Vlado Perkovic1, Jonathan Barratt2, Brad Rovin3

  • 1University of New South Wales, Sydney.

The New England Journal of Medicine
|October 25, 2024
PubMed
Summary
This summary is machine-generated.

Iptacopan significantly reduced proteinuria in patients with IgA nephropathy. This oral medication, targeting the alternative complement pathway, demonstrated a clinically meaningful benefit in a phase 3 trial.

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Area of Science:

  • Nephrology
  • Immunology
  • Pharmacology

Background:

  • The alternative complement pathway is implicated in IgA nephropathy (IgAN) pathogenesis.
  • Iptacopan is an oral medication that inhibits the alternative complement pathway by binding to factor B.

Purpose of the Study:

  • To evaluate the efficacy and safety of iptacopan in reducing proteinuria in adults with IgA nephropathy.
  • To assess the effect of iptacopan compared to placebo on the 24-hour urinary protein-to-creatinine ratio at 9 months.

Main Methods:

  • Phase 3, double-blind, randomized, placebo-controlled trial.
  • Adults with biopsy-confirmed IgAN and proteinuria (24-hour urinary protein-to-creatinine ratio ≥1) were randomized 1:1 to oral iptacopan (200 mg) or placebo twice daily for 24 months.
  • Primary endpoint: change in 24-hour urinary protein-to-creatinine ratio at month 9.

Main Results:

  • An interim analysis at 9 months in 250 patients showed an adjusted geometric mean reduction in proteinuria of 38.3% with iptacopan versus placebo (P<0.001).
  • Secondary endpoints supported the reduction in proteinuria.
  • Iptacopan was well-tolerated, with no unexpected safety findings and similar adverse event incidence compared to placebo.

Conclusions:

  • Iptacopan significantly reduced proteinuria in patients with IgA nephropathy compared to placebo.
  • The observed reduction was clinically meaningful, suggesting iptacopan as a potential treatment for IgAN.