A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy (PROTECT)

Immunoglobulin A Nephropathy (IgAN)

Efficacy End points: The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C) at Week 36., Safety End points: Descriptive statistics will be used to summarize the safety data. All safety evaluations will be conducted based on the Safety Analysis Set. Observed data will be listed by patient., Open-Label Extension Period: Endpoints for the open-label extension period include, but are not necessarily limited to: The absolute and percent change from Week 114 in eGFR at each visit, Open-Label Extension Period: The percent change from Week 114 in UP/C at each visit, Open-Label Extension Period: Changes from Week 114 in QoL at each visit, Open-Label Extension Period: Changes from Week 114 in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters, Open-Label Extension Period: Changes from Week 114 in lipid profile (total cholesterol and triglycerides, low density lipoprotein C, and high density lipoprotein C), Open-Label Extension Period: The incidence of TEAEs during the open-label extension period, Sparsentan + SGLT2 Inhibitor Sub-study: For the Sub-study, the baseline visit (Day 1) is defined as the visit upon which eligibility is assessed. Safety Endpoints: Safety evaluations include the following: Changes from Sub-study baseline in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters at each visit., Sparsentan + SGLT2 Inhibitor Sub-study: The incidence of TEAEs during the Sub-study period., Sparsentan + SGLT2 Inhibitor Sub-study: Efficacy Endpoints: Endpoints include, but are not limited to: The mean change from Sub-study baseline in UP/C and UA/C based on a 24-hour urine sample at the next scheduled visit., Sparsentan + SGLT2 Inhibitor Sub-study: Achievement of urinary protein excretion <0.3 g/day at the next scheduled visit., Sparsentan + SGLT2 Inhibitor Sub-study: Change in absolute and percent change from Sub-study baseline in eGFR at the next scheduled visit.

Rate of change of eGFR

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