PROTECT POST HOC ANALYSIS: EFFICACY OF SPARSENTAN VS IRBESARTAN IN PATIENTS WITH IgA NEPHROPATHY ≤12 MO VS >12 MO FROM KIDNEY BIOPSY

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Abstract Title *

PROTECT POST HOC ANALYSIS: EFFICACY OF SPARSENTAN VS IRBESARTAN IN PATIENTS WITH IgA NEPHROPATHY ≤12 MO VS >12 MO FROM KIDNEY BIOPSY

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Co-author 1

Jonathan Barratt jb81@leicester.ac.uk University of Leicester Department of Cardiovascular Sciences Leicester United Kingdom -

Co-author 2

Radko Komers radko.komers@travere.com Travere Therapeutics, Inc. Clinical Development, Nephrology San Diego United States -

Co-author 3

Stephanie Moody stephanie.moody@travere.com Travere Therapeutics, Inc. Biostatistics San Diego United States -

Co-author 4

Alex Mercer alex.mercer@travere.com JAMCO Pharma Consulting NA Stockholm Sweden -

Co-author 5

Vladimir Tesar vladimir.tesar@vfn.cz General University Hospital, Charles University Department of Nephrology Prague Czech Republic -

Co-author 6

Shikha Wadhwani shwadhwa@utmb.edu University of Texas Medical Branch Department of Medicine Galveston United States *

Co-author 7

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Introduction

Sparsentan, a non-immunosuppressive, dual endothelin angiotensin receptor antagonist (DEARA), showed superior proteinuria reduction and kidney function preservation vs maximum labeled dose irbesartan in the phase 3, randomized, double-blind PROTECT trial. While sparsentan 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 sparsentan vs irbesartan in patients 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). UPCR was also assessed in an analysis where time from biopsy to informed consent was treated as a continuous variable covariate.

Results

Sparsentan showed greater UPCR reduction and slower rate of eGFR decline (slope) vs irbesartan in the ≤12 mo and >12 mo groups (Table; Figure). The treatment effect of sparsentan vs irbesartan on proteinuria was similar in both groups. However, the treatment effect on eGFR slope was greater in the ≤12 mo group vs the >12 mo group. When time from biopsy was analyzed as a continuous variable, sparsentan achieved greater percent reductions in UPCR at week 110 vs irbesartan and consistently across varying numbers of years from biopsy.

Table

Conclusion

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

This abstract was also submitted for the American Society of Nephrology (ASN) Kidney Week 2025 congress.

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