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Abstract: SA-PO901

Sparsentan as First-Line Treatment of Incident Patients with IgA Nephropathy: Preliminary Findings from the SPARTAN Trial

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Cheung, Chee Kay, University of Leicester & Leicester General Hospital, Leicester, United Kingdom
  • Burns, Colleen, Travere Therapeutics Inc, San Diego, California, United States
  • Dhaun, Neeraj, Royal Infirmary of Edinburgh, Edinburgh, Edinburgh, United Kingdom
  • Griffin, Sian V., University Hospital of Wales, Cardiff, Cardiff, United Kingdom
  • Howson, Alexandra Louise, University of Leicester & Leicester General Hospital, Leicester, United Kingdom
  • Komers, Radko, Travere Therapeutics Inc, San Diego, California, United States
  • Mercer, Alex, JAMCO Pharma Consulting, Stockholm, Sweden
  • Sayer, Matthew, Royal Infirmary of Edinburgh, Edinburgh, Edinburgh, United Kingdom
  • Sinha, Smeeta, Salford Royal Hospital Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom
  • Willcocks, Lisa C., Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom
  • Barratt, Jonathan, University of Leicester & Leicester General Hospital, Leicester, United Kingdom
Background

Sparsentan (SPAR) is a novel, non-immunosuppressive, single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved by the US FDA for treatment of adults with IgA nephropathy (IgAN). SPARTAN is an open-label, single-arm, multi-center, exploratory trial, investigating the safety and efficacy of SPAR as first-line therapy in newly diagnosed IgAN patients. We report preliminary findings.

Methods

Patients were aged ≥18 yrs with biopsy-proven IgAN diagnosed within 6 months before enrollment, proteinuria ≥0.5 g/d, and eGFR ≥30 ml/min/1.73m2 at screening. No previous treatment with ACEis/ARBs within the past 12 months was permitted. Patients receive SPAR for 110 wks with 4-wk safety follow-up. In addition to safety monitoring, assessments include proteinuria, estimated and measured GFR, 24h ambulatory blood pressure (BP), and total body water assessment (TBW, bioimpedance). Renal and cardiac MRIs are performed at pre-defined time-points and repeat kidney biopsy at Wk 24.

Results

At data cutoff (4May2023) 6 patients had received ≥1 dose of SPAR with 12 wks follow-up. Mean (SD) age at enrolment was 42 (14) yrs (n=4 female). At baseline, median (IQR) proteinuria was 1.4 (0.6-2.0) g/d, mean (SD) eGFR 67 (27) ml/min/1.73m2 and systolic/diastolic BP 122/80 (7/6) mmHg. Table 1 and Figure 1 summarize data over the first 12 wks. One patient discontinued due to hypotension.

Conclusion

As first-line treatment in newly diagnosed IgAN patients, preliminary findings show SPAR was safe and generally well-tolerated and reduced proteinuria >70% over 12 wks, with reduced total body water over time.

Table 1: Summary data over the first 12 wks (n=6)
 BaselineWk 2Wk 4Wk 6Wk 12
Body weight, kg, mean (SD)83 (29)83 (29)83 (29)83 (29)83 (29)
Total body water, l, mean (SD)47 (4)--44 (10)44 (9)
Achievement of complete remission of proteinuria (<0.3 g/d), n (%)0 (0)0 (0)2 (33)3 (50)2 (33)

Funding

  • Commercial Support – Travere Therapeutics, Inc.