At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 213 enrolled
Drug / intervention
ISIS 416858 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ISIS 416858 and Placebo for End-stage Renal Disease (ESRD). Completed, enrolled 213 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-stage Renal Disease (ESRD)
CountriesSpain
CollaboratorsBayer
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartDec 2017
Primary CompletionJul 2019
TodayJul 2026
First PostedNov 30, 2017
Enrollment StartDec 26, 2017
Primary CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.6 years ago
Interventions
ISIS 416858drug
Subcutaneous injection
Placebodrug
Subcutaneous injection