Concomitant Sparsentan (SPAR) and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Patients with IgA Nephropathy (IgAN) in the PROTECT Open-Label Extension (OLE)
American Society of Nephrology (ASN) Kidney Week – 2024
Effects of Sparsentan after Maximized Angiotensin Receptor Blocker (ARB) Treatment in Patients with IgA Nephropathy (IgAN) in the PROTECT Trial
Poster
Published on June 4, 2025
About the research
Summary
Background
- Sparsentan, a non-immunosuppressive, Dual Endothelin Angiotensin Receptor Antagonist (DEARA) is indicated to slow kidney function decline in adults with primary IgA nephropathy who are at risk for disease progression1-4
- In the double-blind period of the Phase 3 PROTECT trial, sparsentan showed superior proteinuria reduction and kidney function preservation, compared with the maximum labeled dose of irbesartan1,5
- In the PROTECT Open Label Extension (OLE), eligible participants could receive up to 156 weeks of sparsentan, regardless of treatment arm in the double-blind period1
Aim
This analysis of the PROTECT OLE reported the safety and efficacy of sparsentan up to 48 weeks in patients who initiated sparsentan after receiving maximum labeled dose irbesartan for 110 weeks during the double-blind period1
Approach
To be eligible for the PROTECT OLE, participants had to complete 110 weeks of randomized study treatment and have an estimated glomerular filtration rate (eGFR) >20 mL/min/1.73 m2 at Week 1101
Key findings
In PROTECT OLE period (n=128), sparsentan demonstrated1:
- A rapid reduction in urine protein-creatinine ratio (UPCR) that was sustained for up to 48 weeks1
- Mean UPCR was reduced from 1.2 g/g at Week 0 (95% confidence interval [CI]: 1.0-1.4) to 0.6 g/g at Week 48 (95% CI: 0.5-0.7)
- Stable eGFR values and well-controlled BP for up to 48 weeks1
In the PROTECT OLE period, adverse event (AE) rates were low with no new safety signals1
Conclusions
- In PROTECT, patients with IgA nephropathy who previously received maximum labeled dose irbesartan for 2 years, experienced rapid and sustained proteinuria reductions after initiating sparsentan in the OLE period1
- Sparsentan was generally well tolerated, and no new safety signals were seen1
Related content
Footnotes
BP, blood pressure; CI, confidence interval; DEARA, Dual Endothelin Angiotensin Receptor Antagonist; eGFR, estimated glomerular filtration rate; IgAN, IgA nephropathy; OLE, open label extension; UPCR, urine protein-creatinine ratio.
- Floege J et al. Poster presented at: European Renal Association 2025; June 4-7, 2025; Vienna, Austria.
- Kohan DE et al. Clin Sci (Lond). 2024;138(11):645-662.
- Trachtman H et al. Expert Rev Clin Immunol. 2024;20(6):571-576.
- FILSPARI® (sparsentan) Prescribing Information. San Diego, CA: Travere Therapeutics, Inc. 9/2024.
- Rovin BH et al. Lancet. 2023;402(10417):2077-2090.
MA-SP-25-0101 | July 2025