A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN (SPARTACUS)
Immunoglobulin A Nephropathy
About this trial
This is an interventional treatment trial for Immunoglobulin A Nephropathy focused on measuring IgAN
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/1.73m2 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) Exclusion Criteria: IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis. Undergone any organ transplant, with the exception of corneal transplants. Documented history of heart failure, clinically significant cardiovascular or liver disease. Taking high dose (defined as >10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.
Sites / Locations
- Travere Investigational SiteRecruiting
- Travere Investigational Site
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
- Travere Investigational SiteRecruiting
Arms of the Study
Arm 1
Experimental
sparsentan
Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.