Abstract: FR-OR63
Sparsentan (SPAR) as First-Line Treatment of Incident Patients with IgA Nephropathy: Interim Analysis of the SPARTAN Trial
Session Information
- IgA Nephropathy: New Therapies and Insights
October 25, 2024 | Location: Room 6D, Convention Center
Abstract Time: 05:40 PM - 05:50 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Cheung, Chee Kay, University of Leicester & Leicester General Hospital, Leicester, United Kingdom
- Moody, Stephanie, Travere Therapeutics, Inc., San Diego, California, United States
- Dhaun, Neeraj, Department of Renal Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
- Griffin, Sian V., Department of Nephrology and Transplantation, University Hospital of Wales, 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, Department of Renal Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
- Sinha, Smeeta, Department of Renal Medicine Salford Royal Hospital Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom
- Willcocks, Lisa C., Department of Renal Medicine, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom
- Barratt, Jonathan, University of Leicester & Leicester General Hospital, Leicester, United Kingdom
Background
SPAR is a nonimmunosuppressive, dual endothelin and angiotensin receptor antagonist (DEARA) approved in the US and EU for the treatment of adults with IgAN. SPARTAN (NCT04663204) is an open-label, single-arm, multicenter, exploratory trial investigating the safety, efficacy, and mechanistic action of SPAR as first-line therapy in patients newly diagnosed with IgAN. We report interim findings.
Methods
Twelve patients ≥18 y old with biopsy-proven IgAN, proteinuria of ≥0.5 g/d, eGFR of ≥30 mL/min/1.73 m2, and no prior treatment with ACEis/ARBs (≤12 mo) were enrolled. SPAR is given for 110 wk with 4-wk safety follow-up. In a prespecified 24-wk interim analysis, proteinuria, GFR, BP, body weight, total body water (bioimpedance), and safety were assessed.
Results
Mean age at enrollment was 35.8 (SD 12.2) y (5 female), with median (IQR) proteinuria of 1.7 (0.6-3.3) g/d and mean eGFR of 70.2 (SD 25.0) mL/min/1.73 m2 at baseline (BL). Proteinuria reductions were rapid (−61.9% [±SE −66.9 to −56.1] from BL to wk 4) and sustained over 24 wk (Figure); 58% of patients achieved complete proteinuria remission (<0.3 g/d) at any time during the first 24 wk of treatment. After an initial decrease from BL (125/78 mm Hg), BP remained stable during follow-up; eGFR, total body water, and body weight were generally stable (Table). The most frequent AE was dizziness (50% of patients); 1 patient discontinued due to hypotension.
Conclusion
In patients newly diagnosed with IgAN, interim findings show that SPAR as first-line treatment was generally well tolerated and reduced proteinuria ≈70% over 24 wk.
Summary Interim Data Over 24 Wk
| Mean change from baseline (SD) | Week 2 (n=12) | Week 4 (n=11) | Week 6 (n=11) | Week 12 (n=11) | Week 24 (n=11) |
| Weight, kg | −0.3 (0.7) | −0.2 (1.4) | 0.2 (1.4) | 0.1 (2.7) | −1.0 (3.3) |
| Total body water, L | – | – | −2.2 (7.5) | −2.0 (7.5) | −2.4 (7.4) |
| Office BP, mm Hg Systolic Diastolic | −7 (7) −7 (11) | −13 (9) −7 (8) | −12 (9) −7 (9) | −13 (7) −7 (7) | −15 (6) −8 (9) |
| Ambulatory BP, mm Hg Systolic Diastolic | – – | – – | −12 (12)* −9 (9)* | – – | – – |
| eGFR, mL/min/1.73 m2 | 1.1 (7.6) | −3.4 (6.5) | −1.3 (5.1) | 1.3 (6.5) | −5.6 (6.2) |
*n=7.
Funding
- Commercial Support – Travere Therapeutics, Inc.