SPARSENTAN:
SPARTAN and PROTECT
Increased production of ET 1 has been associated with progression of IgA nephropathy. Sparsentan is a novel single-molecule dual endothelin angiotensin receptor antagonist with hemodynamic and anti-inflammatory properties.
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How is Sparsentan being studied in IgA nephropathy?
SPARTAN is a phase 2 single center (University of Leicester, United Kingdom), open-label, single-group study to explore the safety of, and response to sparsentan treatment (200-400 mg) in incident, renin angiotensin system (RAS) blockade-naïve patients with biopsy-proven immunoglobulin A nephropathy (IgAN). The purpose is to explore sparsentan treatment as a potential first-line treatment in patients newly diagnosed with IgAN (ie, incident patients), who have thus not received prior treatment with ACEI or ARB therapy for IgAN. Trial plans to recruit 12 participants. All patients will be treated with sparsentan for a total of 110 weeks, followed by an off-treatment follow-up period of 4 weeks.
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PROTECT is a phase 3 trial in patients with IgAN. The trial is still active however not recruiting.Â
 Trial plans to recruit 380 patients aged ≥18 years who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an ACEI and/or ARB that is a maximum tolerated dose. They will be randomly assigned in a 1:1 ratio to either sparsentan single oral AM dose or 300 mg irbesartan, as the active controlÂ
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This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks.
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In Feb 2023, FILSPARI™ (sparsentan) received accelerated approval from the U.S. Food and Drug Administration (FDA) for treatment of IgA nephropathy. This indication is granted under accelerated approval based on reduction in proteinuria. It has not been established whether FILSPARI slows kidney function decline in patients with IgAN. The continued approval of FILSPARI may be contingent upon confirmation of a clinical benefit in the ongoing Phase 3 PROTECT Study, which is designed to demonstrate whether FILSPARI slows kidney function decline.
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Because of the risks of hepatotoxicity and birth defects, FILSPARI is available only through a restricted program called the FILSPARI REMS.
Eligibility Criteria
Diagnosed with biopsy-proven IgAN within the last 3 months.
Proteinuria of ≥0.5 g/day at screening
eGFR ≥30 mL/min/1.73 m2 at screening.
Women of childbearing potential (WOCBP) to agree to contraception
Not previously treated with ACEI and/or ARB therapy for IgAN OR has not received ACEI and/or ARB therapy within the last 12 months
Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.