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NCT04534114 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 307
- Enrollment target
NCT04534114: Completed Phase 2 study, sponsored by Bayer.
NCT04534114 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 307 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (131% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534114, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 307 participants
- Enrollment target
Study 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.
Primary Outcome
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit th
Interventions
- DRUG Placebo
- DRUG Fesomersen sodium (BAY2976217)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2020-09-04 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 2 |
What the finished NCT04534114 record still lists
NCT04534114 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (131% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04534114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534114 about?
NCT04534114 is a clinical study titled "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". 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...
What is the current status of trial NCT04534114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2020-09-04. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT04534114?
The interventions under investigation include: Placebo (DRUG), Fesomersen sodium (BAY2976217) (DRUG).
Who is sponsoring clinical trial NCT04534114?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534114's enrollment target sits among peer trials
307 165th of 2000 higher than 1,836 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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