ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Please note that you are viewing an archived section from 2022 and some content may be unavailable. To unlock all content for 2022, please visit the archives.

Abstract: FR-OR57

Long-Term Efficacy and Safety of Sparsentan in FSGS: 240-Week Analysis of the DUET Open-Label Extension (OLE)

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials

Authors

  • Srivastava, Tarak, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
  • Tesar, Vladimir, Charles University, General University Hospital, Prague, Czechia
  • Campbell, Kirk N., Ichan School of Medicine at Mount Sinai, New York, New York, United States
  • Rheault, Michelle N., University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, United States
  • Komers, Radko, Travere Therapeutics Inc, San Diego, California, United States
  • Murphy, Edward, Travere Therapeutics Inc, San Diego, California, United States
  • Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States
  • Gesualdo, Loreto, University of Bari Aldo Moro, Bari, Italy
Background

Sparsentan (SPAR) is a novel, orally active, single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) being investigated for focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy. In the 8-week double-blind period of the phase 2 DUET trial in patients with FSGS (excluding secondary FSGS), SPAR (200, 400, and 800 mg/day) resulted in greater proteinuria reduction vs irbesartan 300 mg/day. The 240-week analysis of the DUET OLE reports the on-treatment long-term efficacy and safety of SPAR.

Methods

Patients (n=108 who received ≥1 SPAR dose) were examined from first SPAR dose (double-blind or OLE) through 240 weeks (4.6 years). Urinary protein/creatinine ratio (UP/C), eGFR, and blood pressure (BP) were assessed every ~12 weeks. Treatment-emergent adverse events (TEAEs) and treatment-related TEAEs were summarized as cases per 100 patient-years.

Results

At OLE data cutoff (February 5, 2021), 45/108 patients (41.7%) had ongoing SPAR treatment. Total patient years with SPAR were 366. Median years to treatment discontinuation was 3.9. At Week 240 vs baseline, median (IQR) UP/C was 0.80 g/g (0.33, 2.55; n=41) vs 2.7 g/g (1.5, 4.2; n=107) and eGFR was 57.8 mL/min/1.73m2 (34.3, 71.4; n=45) vs 69.4 mL/min/1.73m2 (44.1, 92.0; n=108). Systolic/diastolic BP (mean±SD) was 122.9±15.0/76.1±9.6 mmHg (n=47) vs 129.0±12.4/81.6±8.8 mmHg (n=108). Table shows the most common TEAEs and the cases considered treatment-related.

Conclusion

Sustained proteinuria reduction was observed over 240 weeks in patients who continued SPAR in the OLE. No new or unexpected TEAEs vs the double-blind period were observed with long-term SPAR treatment.

Funding

  • Commercial Support –