A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

Launched by TRAVERE THERAPEUTICS, INC. · May 3, 2023

Keywords

ClinConnect Summary

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry.

Participants who provide written informed consent will be assessed for eligibility and will undergo baseline evaluations including clinical laboratory tes...

Gender

ALL

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.