Phase 2 N=213 Randomized Quadruple-blind Prevention

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

End-stage Renal Disease (ESRD)

Bottom Line

View on ClinicalTrials.gov: NCT03358030 ↗

Enrolled (actual)

213

Serious AEs

23.3%

Results posted

Jan 2023

Primary outcome: Primary: Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB) — 3; 2; 3; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ISIS 416858 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ionis Pharmaceuticals, Inc.
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB)	3; 2; 3; 3	—

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.

Eligibility Criteria

Inclusion Criteria

End stage renal disease maintained on outpatient hemodialysis at a healthcare center for > 3 months from screening with hemodialysis at least 3 times per week for a minimum of 9 hours per week of prescribed treatment time and plan to continue this throughout the study.

Exclusion Criteria

Participants with a history of major medical event (previous acute coronary syndrome, stroke or transient ischemic attack or systemic thromboembolic event) within 3 months of screening, major surgery within 3 months of screening, or new major physical examination finding except for documented atrial fibrillation
Active bleeding within the past 3 months from screening or documented bleeding diathesis (excluding uremia), coagulopathy, or recent prolonged compression time at arteriovenous fistula
Screening values of:
Platelet count 1.4
Activated partial thromboplastin time (aPTT) > upper limit of normal (ULN)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
Total bilirubin > ULN
Factor XI (FXI) activity 180 millimeters of mercury (mmHg) on at least 3 of last 5 dialysis treatments.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03358030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.