NCT04534114

Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease Requiring Hemodialysis

Interventions

Type	Name	Description
DRUG	Fesomersen sodium (BAY2976217)	Study intervention will be injected subcutaneously.
DRUG	Placebo	Matching placebo to BAY2976217 will be injected subcutaneously.

Timeline

• Start date: 2020-09-04
• Primary completion: 2022-01-24
• Completion: 2022-05-12
• First posted: 2020-09-01
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

69 sites across 15 countries: United States, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Japan, Latvia, Russia, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study