NCT04523220

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 704 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Conditions

• End-stage Renal Disease
• Prevention of Thromboembolic Events
• Hemodialysis
• Hemodiafiltration

Interventions

Type	Name	Description
DRUG	BAY1213790 (Osocimab)	Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
DRUG	Placebo	Subcutaneous administration in the same manner as Osocimab.

Timeline

• Start date: 2020-08-28
• Primary completion: 2021-12-28
• Completion: 2022-05-30
• First posted: 2020-08-21
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

151 sites across 19 countries: United States, Australia, Austria, Belgium, Bulgaria, Czechia, Greece, Hungary, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study