Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534114
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2020-08-20
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
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
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-THINc ESRD
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003927-39 | EUDRACT_NUMBER | None | None |