MO254: Baseline Characteristics of Patients Enrolled in the Ongoing Phase 3 Randomized, Double-Blind, Active-Control Trial of Sparsentan for the Treatment of Focal Segmental Glomerulosclerosis (DUPLEX)

Abstract

Abstract BACKGROUND AND AIMS Uncontrolled focal segmental glomerulosclerosis (FSGS) often follows a progressive course to end-stage kidney disease and has a profound negative impact on patient quality of life and long-term survival. Treatments that reduce proteinuria and risk of kidney disease progression are urgently needed. Sparsentan is a novel dual endothelin angiotensin receptor antagonist (DEARA) being investigated for FSGS. The Phase 3 DUPLEX study is examining the potential long-term antiproteinuric and nephroprotective potential and safety of sparsentan compared with an active control, angiotensin receptor blocker (ARB) irbesartan in adults and pediatric patients with FSGS. Here we report the baseline characteristics for all patients enrolled in the DUPLEX trial. METHOD DUPLEX is an ongoing, global, Phase 3, multicenter, randomized, double-blind, active-controlled study designed to evaluate the efficacy and safety of sparsentan versus irbesartan in adult and pediatric patients (≥8–75 years old) with FSGS. The study duration is 268 weeks: a 112-week double-blind period followed by an open-label extension period of up to 156 weeks. The primary efficacy endpoint is the slope of eGFR over approximately 2 years of randomized treatment. Key inclusion and exclusion criteria are shown in Table 1. Patients receiving renin–angiotensin–aldosterone system (RAAS) inhibitors underwent a 2-week washout prior to randomization. Patients were randomized 1:1 to sparsentan or irbesartan (target dose 800 and 300 mg/day, respectively), stratified by screening eGFR and urine protein/creatinine ratio (UP/C). The blinded and aggregated baseline characteristics of all patients enrolled in the DUPLEX trial are summarized descriptively. RESULTS The DUPLEX study is fully enrolled with 371 patients (336 adult and 35 pediatric) across 179 study sites in 22 countries. Selected demographic and clinical characteristics in the total population are reported in Table 2. CONCLUSION DUPLEX is the largest randomized controlled trial to date in FSGS. Patients with FSGS enrolled in the DUPLEX trial display demographic and clinical characteristics consistent with the profile previously reported in the broader population of patients globally with FSGS not in remission.