The objective of the 416858-CS4 study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS 416858 in End-Stage Renal Disease (ESRD) patient on hemodialysis. (ISIS-FXI-RX is an Antisense Inhibitor of Factor.)

This study demonstrated that:

  • Hemodialysis had no effect on IONIS-FXIRx pharmacokinetics
  • IONIS-FXIRx was well tolerated and produced sustained, and dose-dependent reductions in FXI antigen and activity
  • IONIS-FXIRx reduced severe dialysis circuit clotting events beyond standard heparin use.
  • These data support further evaluation of IONIS-FXIRx as a potentially safe, effective antithrombotic therapy in ESRD patients on hemodialysis
Study Type

Interventional - Drug

Study Design

Phase 2 double blind, placebo controlled RCT

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2015 - 2016


IONIS Pharmaceuticals

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