A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
A Multicentered, Single-group Phase 2, Exploratory, Open-label Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in the Treatment of Adult Participants With Immunoglobulin A Nephropathy (IgAN)
Sponsor: Travere Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24
Time frame: Week 24
Secondary Endpoints
UA/C <0.2 g/g at Week 24
30% Reduction From Baseline in UA/C at Week 24
50% Reduction From Baseline in UA/C at Week 24
Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years at the time of signing the informed consent. * Biopsy-proven IgAN. The biopsy may have been performed at any time in the past. * UA/C ≥0.3 g/g at screening * An eGFR value of ≥25 mL/min/1.73m\^2 at screening. * On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening. * On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is: * The participant's maximum tolerated dose (MTD), and * at least one half of the maximum labeled dose (MLD) * Systolic BP must be ≤160 mmHg, and diastolic BP must be ≤110 mmHg at screening. * For participants receiving chronic low dose systemic corticosteroids (defined as ≤10 mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or a mineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeks prior to screening. Exclusion Criteria: * IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis. * Unde…
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