PROTECT

Sparsentan in IgA Nephropathy

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 404 patients with IgA nephropathy and proteinuria despite maximal RAS blockade, sparsentan reduced proteinuria compared with irbesartan.

404

Disegno

Phase 3 double-blind, active-controlled RCT

Esito

Change in urine protein:creatinine ratio at week 36

Rilevanza

Risultato−49.8% vs −15.1% at week 36 (ratio 0.59, 95% CI 0.51–0.69; p<0.0001); eGFR chronic slope difference 1.1 mL/min/1.73m²/yr (95% CI 0.1–2.1; p=0.037) over 2 years.

Rovin BH, et al. Lancet. 2023;402(10417):2077-2090. 10.1016/S0140-6736(23)00569-X

Discussione e critica

Dual endothelin/angiotensin antagonism; supported accelerated then full FDA approval of Filspari for IgA nephropathy.