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

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.

Timeline

Start

2020-09-04

Primary completion

2022-01-24

Completion

2022-05-12

Outcome

Missed primary endpoint

registry Fesomersen 40 mg vs Placebo; p = 0.944; Cause specific Hazard ratio 0.94 (95% CI 0.19 to 4.68); Log Rank NCT04534114 ↗

Publications

• Stamellou E, Noels H, Floege J. Factor XI inhibition in hemodialysis patients: the safer anticoagulation? Kidney Int. 2024 Jul;106(1):21-23. doi: 10.1016/j.kint.2024.03.029.
• Winkelmayer WC, Lensing AWA, Thadhani RI, Mahaffey KW, Walsh M, Pap AF, Willmann S, Thelen K, Hodge S, Solms A, Ingham SJM, Eikelboom J; RE-THINC investigators. A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis. Kidney Int. 2024 Jul;106(1):145-153. doi: 10.1016/j.kint.2024.02.024. Epub 2024 Mar 26.

Drugs

Indications