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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
North America Research Institute - Azusa
Azusa, California, United States
Fresenius Kidney Care - Brawley
Brawley, California, United States
DaVita South Valley Dialysis
Encino, California, United States
Fresenius Kidney Care - La Mesa
La Mesa, California, United States
East L.A. Dialysis Center
Los Angeles, California, United States
Van Buren Dialysis Center
Riverside, California, United States
Fresenius Kidney Care Kearny Mesa
San Diego, California, United States
FMC San Ysidro
San Diego, California, United States
Queen's Dialysis Unit
West Covina, California, United States
DaVita Greater Waterbury Dialysis
Waterbury, Connecticut, United States
Start Date
August 28, 2020
Primary Completion Date
December 28, 2021
Completion Date
May 30, 2022
Last Updated
July 21, 2023
704
ACTUAL participants
BAY1213790 (Osocimab)
DRUG
Placebo
DRUG
Lead Sponsor
Bayer
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06933472