SONAR

Study of Diabetic Nephropathy with Atrasentan

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 2,648 patients with type 2 diabetes and CKD selected for response, atrasentan reduced the composite of creatinine doubling or ESKD compared with placebo.

2648

Disegno

Double-blind RCT, enrichment (responder) design

Esito

Doubling of serum creatinine or ESKD

Rilevanza

RisultatoHR 0.65 (95% CI 0.49–0.88; p=0.0047); more fluid retention and oedema with atrasentan.

Heerspink HJL, et al. Lancet. 2019;393(10184):1937-1947. 10.1016/S0140-6736(19)30772-X

Discussione e critica

Proof of concept for selective endothelin-A antagonism; the enrichment design limits generalisability.