Kidney Week

Abstract: FR-PO849

Concomitant Sparsentan (SPAR) and SGLT2 Inhibitors in Adults with IgA Nephropathy in the Ongoing Phase 2 SPARTACUS Trial

Session Information

• IgA Nephropathy: Clinical, Outcomes, and Therapeutics
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Ayoub, Isabelle, Division of Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Isabelle Ayoub, MD, MPH, FASN

• Tang, Sydney, Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China

Sydney Tang, MD, MBBS, PhD

• Kooienga, Laura, Colorado Kidney Care, Denver, Colorado, United States

Laura Kooienga, MD

• Preciado, Priscila, Travere Therapeutics, Inc., San Diego, California, United States

Priscila Preciado, MD

• Lee, David S., Travere Therapeutics, Inc., San Diego, California, United States

David S. Lee, MS

• Moody, Stephanie, Travere Therapeutics, Inc., San Diego, California, United States

Stephanie Moody, MS

• Rovin, Brad H., Division of Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Brad H. Rovin, MD, FASN

Background

SPAR is a nonimmunosuppressive, dual endothelin angiotensin receptor antagonist (DEARA) approved in the US and EU for adults with IgAN. In patients (pts) with IgAN, SPAR showed sustained proteinuria reduction and preservation of kidney function in the phase 3 PROTECT trial. In a subgroup analysis from DAPA-CKD and EMPA-KIDNEY, SGLT2is reduced the risk of progression to kidney failure in pts with IgAN. The combination of SPAR and an SGLT2i may therefore provide therapeutic benefits with potentially additive kidney protection. The ongoing phase 2 SPARTACUS trial will evaluate the efficacy and safety of SPAR added to an SGLT2i in adults with IgAN.

Methods

SPARTACUS is a 28-wk, open-label, multicenter study of the efficacy and safety of SPAR added to a stable SGLT2i in pts with IgAN at high risk of disease progression. Pts had biopsy-proven IgAN, urine albumin-to-creatinine ratio (UACR) of ≥0.3 g/g, and an estimated glomerular filtration rate (eGFR) of ≥25 mL/min/1.73 m² despite a stable SGLT2i and maximized renin-angiotensin-system inhibition for ≥12 wk. Endpoints include change from baseline in UACR at wk 24 (primary); achievement of UACR of <0.2 g/g or 30% or 50% reduction in UACR at wk 24 (secondary); change from baseline in UACR, urine protein-to-creatinine ratio, eGFR, and blood pressure at each visit (secondary); and adverse events. We describe pts in a prespecified interim analysis 24 wk after ≈20 pts were enrolled.

Results

Pt demographics and baseline characteristics are reported in the Table.

Conclusion

Enrollment in SPARTACUS will allow for assessment of the efficacy and safety of SPAR added to a stable SGLT2i in pts with IgAN. The presentation will include data from the interim analysis.

Funding

• Commercial Support – Travere Therapeutics, Inc.