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Kidney Week

Abstract: FR-PO0807

PROTECT Post Hoc Analysis: Efficacy of Sparsentan (SPAR) vs. Irbesartan (IRB) in Patients (Pts) with IgAN ≤12 mo vs. >12 mo from Kidney Biopsy

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Wadhwani, Shikha, The University of Texas Medical Branch at Galveston, Galveston, Texas, United States
  • Barratt, Jonathan, University of Leicester, Leicester, England, United Kingdom
  • Komers, Radko, Travere Therapeutics Inc, San Diego, California, United States
  • Moody, Stephanie, Travere Therapeutics Inc, San Diego, California, United States
  • Tesar, Vladimir, Vseobecna fakultni nemocnice v Praze, Prague, Czechia
Background

SPAR, a non-immunosuppressive, dual endothelin angiotensin receptor antagonist (DEARA), showed superior proteinuria reduction and kidney function preservation vs maximum labeled dose IRB in the phase 3, randomized, double-blind PROTECT trial. While SPAR was favored across multiple prespecified subgroups, it is not known whether time from biopsy to informed consent affects efficacy.

Methods

This post hoc analysis assessed the efficacy of SPAR vs IRB in pts with ≤12 mo vs >12 mo between biopsy and time of informed consent (ie, recent vs older biopsies). Endpoints included urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).

Results

SPAR showed greater UPCR reduction and slower rate of eGFR decline (slope) vs IRB in both groups (Table; Figure). The treatment effect of SPAR vs IRB on proteinuria was similar in both groups. However, the treatment effect on eGFR slope was greater in the ≤12-mo group.

Conclusion

SPAR showed better efficacy vs maximum labeled dose IRB regardless of time from biopsy, with greater kidney preservation with shorter time from biopsy. These results emphasize the value of early SPAR treatment.

Funding

  • Commercial Support – Travere Therapeutics

Digital Object Identifier (DOI)