NCT03358030

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End-stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	ISIS 416858	Subcutaneous injection
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2017-12-26
• Primary completion: 2019-07-10
• Completion: 2019-07-10
• First posted: 2017-11-30
• Last updated: 2023-01-20
• Results posted: 2023-01-20

Locations

2 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study