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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
704
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
Subcutaneous administration in the same manner as Osocimab.
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
Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events \[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.
Time frame: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.
Time frame: From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).
Time frame: At 6 months (Visit 19 / Day 30 of the 6th month)
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.
Time frame: At 6 months (Visit 19 / Day 30 of the 6th month)
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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
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