Phase 2 Study of the Factor XI Antisense Inhibitor IONIS-FXI_Rx in Patients With ESRD.

ABSTRACT:

Introduction

Patients with end-stage renal disease (ESRD) requiring hemodialysis (HD) have an increased risk of thrombotic events and bleeding. Antisense reduction of factor XI (FXI) with IONIS-FXI_Rx is a novel strategy that may safely reduce the risk of thrombotic events.

Methods

This multicenter study enrolled 49 patients receiving HD in 2 parts. First, 6 participants (pharmacokinetics [PK] cohort) received 1 open-label 300 mg dose of IONIS-FXI_Rx both before and after HD. Subsequently, 43 participants were treated in a double-blind, randomized design with 200 mg or 300 mg IONIS-FXI_Rx or placebo for 12 weeks. The PK, pharmacodynamics (PD), and adverse events of IONIS-FXI_Rx were evaluated (ClinicalTrials.gov: NCT02553889).

Resul

SUBMITTER: Walsh M 

PROVIDER: S-EPMC8820988 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature