SONAR

Study of Diabetic Nephropathy with Atrasentan

Paciente / Población Intervención / Exposición Comparación Desenlace

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

Diseño

Double-blind RCT, enrichment (responder) design

Desenlace

Doubling of serum creatinine or ESKD

Relevancia

ResultadoHR 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

Discusión y crítica

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