The PROTECT study is an ongoing,* randomized, double-blinded, head-to-head, multicenter, global study comparing FILSPARI vs irbesartan³

*Patients participating in the open-label extension (OLE) period may be evaluated for eligibility to participate in the OLE sub study. The OLE of PROTECT is currently ongoing^5
†On Day 1, patients were randomized 1:1 to FILSPARI or irbesartan^2
‡One patient in each arm did not receive the study drug and was excluded^2
§Before the randomization visit, participants discontinued prohibited concomitant medications, including RASi. The initial study drug dose for the first 2 weeks was half of the target dose (200 mg oral FILSPARI once daily; 150 mg oral irbesartan once daily). At the Week 2 visit, doses were titrated to the target dose (400 mg FILSPARI once daily; 300 mg irbesartan once daily) following evaluation of dose tolerability. Dose tolerance was defined as systolic BP higher than 100 mmHg, diastolic BP higher than 60 mmHg and no TEAEs. Participants with asymptomatic BP of 100/60 mmHg or less continued the initial dose. Dose titrations (down or back up) were permitted at any time at the investigator’s discretion²
**Starting dose of FILSPARI for the open-label extension was 200 mg. Titration to 400 mg was based on tolerability after 2 weeks of treatment in the open-label extension^6
††Confirmatory endpoint required by the EMA^6
‡‡Confirmatory endpoint required by the FDA⁶