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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

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
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