AB023

Evidence outlook · lead readout

NCT03612856 · End Stage Renal Disease, Thrombosis

The completed lead evidence is positive, with design limits that temper confidence — see the rationale below for exactly which.

NCT03612856: This is a randomized, quadruple-blind, placebo-controlled trial, but it is small (24 patients, 8 per arm) and its primary endpoints are descriptive safety/tolerability outcomes (treatment-emergent adverse events, vascular-access bleeding, laboratory and ECG changes) reported without formal statistical testing. The results show no treatment-related AEs in any arm and more bleeding events in the 0.5 mg/kg arm than placebo (5 vs 3), but no significance testing was performed, so the evidence is limited by the underpowered, descriptive design.