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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