DUPLEX
Sparsentan in Focal Segmental Glomerulosclerosis
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 371 patients with focal segmental glomerulosclerosis, sparsentan reduced proteinuria but did not significantly improve eGFR slope compared with irbesartan.
N
371
Design
Phase 3 active-controlled RCT
Endpunkt
eGFR slope over 108 weeks
Relevanz
3
ErgebnisTotal-slope difference +0.3 mL/min/1.73m²/yr (95% CI −1.7 to 2.4; primary eGFR-slope endpoint missed); FSGS partial remission 42.0% vs 26.0% (p=0.009).
Rheault MN, et al. N Engl J Med. 2023;389(26):2436-2445. 10.1056/NEJMoa2308550
Diskussion & Kritik
A clean example of proteinuria reduction without an eGFR-slope benefit; no FSGS approval, unlike for IgA nephropathy.