CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 307 enrolled
Drug / intervention
Fesomersen sodium (BAY2976217) +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.

Search/NCT04534114
NCT04534114Phase 2Completed

Factor XI LICA to Reduce Thrombotic Events in End-Stage Renal Disease Patients on Hemodialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of BAY 2976217

Bayer·interventional·Posted Sep 1, 2020·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating Fesomersen sodium (BAY2976217) and Placebo for End Stage Renal Disease Requiring Hemodialysis. Completed, enrolled 307 participants across 69 sites in 15 countries.

Detailed Summary

Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other life-threatening conditions. BAY2976217 is under clinical development for prevention of thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as multiple doses in participants with renal impairment who require hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Japan, Latvia, Russia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 1, 2020
Enrollment StartSep 4, 2020
Primary CompletionJan 24, 2022
Study CompletionMay 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.8 years ago

Interventions

Fesomersen sodium (BAY2976217)drug

Study intervention will be injected subcutaneously.

Placebodrug

Matching placebo to BAY2976217 will be injected subcutaneously.