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
Concomitant Sparsentan and Sodium-Glucose Cotransporter-2 Inhibitors in Adults With IgA Nephropathy in the Ongoing Phase 2 SPARTACUS Trial
Poster
Published on October 25, 2024
About the research
Summary
Background
- Sparsentan is a non-immunosuppressive, Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in adults with IgA nephropathy who are at risk for disease progression1-5
- It has demonstrated sustained proteinuria reduction and preservation of kidney function in the Phase 3 PROTECT study6
- In clinical studies, sodium-glucose cotransporter-2 inhibitors (SGLT2i) have reduced proteinuria and the risk of progression to kidney failure in patients with IgA nephropathy7,8
- Combining sparsentan with a stable SGLT2i may provide therapeutic benefits1
Aim
- The ongoing Phase 2 SPARTACUS trial will evaluate the efficacy and safety of sparsentan added to stable SGLT2i treatment in adults with IgA nephropathy1
- Prior to screening, all patients were on a renin-angiotensin system inhibitor (RASi) and SGLT2i. At the start of the study, patients switched from a RASi to sparsentan and maintained a stable SGLT2i1
Approach
- SPARTACUS is a 24-week Phase 2, exploratory, open-label, single-arm, multicenter study of sparsentan when added to a stable SGLT2i in patients with IgA nephropathy at risk of disease progression1
Key findings
Adding sparsentan to a stable SGLT2i1:
- Demonstrated rapid and sustained reductions in urine albumin-creatinine ratio (UACR) and urine protein-creatinine ratio (UPCR)
- Led to patients reaching target response endpoints
- 57.9% of patients experienced a ≥30% reduction and 31.6% of patients experienced a ≥50% reduction in UACR from baseline
- Showed relatively stable estimated glomerular filtration rate (eGFR) levels during the study
- Showed slightly decreased blood pressure
Adding sparsentan to a stable SGLT2i was generally well tolerated with no unexpected safety signals1
Read more about concomitant use of sparsentan and an SGLT2i in the PROTECT open-label extension (OLE) study and in a case series describing real-world experience.
Conclusion
- Switching from a RASi to sparsentan on a stable SGLT2i resulted in further reduction of proteinuria, thus lowering the risk for disease progression and was generally well tolerated1
- This study is ongoing, and future analyses will report results from a larger number of patients1
Related content
Footnotes
DEARA, Dual Endothelin Angiotensin Receptor Antagonist; eGFR, estimated glomerular filtration rate; IgA, immunoglobulin; OLE, open-label extension; RASi, renin-angiotensin system inhibitor; SGLT2i, sodium-glucose cotransporter-2 inhibitor; UACR, urine albumin-creatinine ratio; UPCR, urine protein-creatinine ratio.
- Ayoub I et al. Poster presented at: American Society of Nephrology Kidney Week 2024; October 23-27, 2024; San Diego, CA. FR-PO849.
- Kohan DE et al. Clin Sci. 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.
- FILSPARI® (sparsentan) Summary of Product Characteristics. Paris, France: Vifor France. 7/2024.
- Rovin BH et al. Lancet. 2023;402(10417):2077-2090.
- Wheeler DC et al. Kidney Int. 2021;100(1):215-224.
- EMPA-KIDNEY Collaborative Group. Lancet Diabetes Endocrinol. 2024;12(1):51‑60.
MA-SP-24-0131 | October 2024