A Study of ISIS 416858 Administered Subcutaneously to Participants With

A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis — EMERALD

End-stage Renal Disease (ESRD) Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX, an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis

Status Completed

Clinical Trial Summary

Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS 416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI activity reduction.

Clinical Trial Description

Evaluation of safety, PK, and PD of ISIS 416858 (Dose # 1, Dose #2 and Dose #3 once weekly) as compared to placebo as assessed by FXI activity reduction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03358030
Study type	Interventional
Source	Ionis Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	December 26, 2017
Completion date	July 10, 2019

View Details

See also
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