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

Completed · Phase 2 · Has a placebo group

Conditions studied: End-stage Renal Disease, Prevention of Thromboembolic Events, Hemodialysis, Hemodiafiltration

In brief

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.

Key facts

Study ID

NCT04523220

Run by

Bayer

People needed

704

Starts

2020-08-28

Expected to finish

2022-05-30

Last updated by the study team

2023-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be at least 18 years of age
• Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
• Body weight of at least 50 kg
• Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

• Recent (<6 months before screening) clinically significant bleeding
• Hemoglobin (Hb) < 9.0 g/dL at screening
• Platelet count < 100 x 10\^9/L
• aPTT or PT > ULN (upper limit of normal)
• Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
• Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
• Known intracranial neoplasm, arteriovenous malformation or aneurysm
• Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
• Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
• Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
• Scheduled living donor renal transplant during study participation
• Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
• Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
• Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

Where it is running

• 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
• ARA Plantation Dialysis, LLC — Ellenton, Florida, United States
• ARA Augusta — Augusta, Georgia, United States
• Liberty Dialysis- Caldwell — Caldwell, Idaho, United States
• Fresenius Kidney Care Evergreen Park — Evergreen Park, Illinois, United States
• Fresenius Kidney Care Baton Rouge Mancuso Lane — Baton Rouge, Louisiana, United States
• Fresenius Kidney Care South Dialysis — Shreveport, Louisiana, United States
• ARA Holyoke Dialysis Center — Holyoke, Massachusetts, United States
• Davita Hospital Hill Dialysis — Kansas City, Missouri, United States
• Renal Medicine Associates — Albuquerque, New Mexico, United States
• Durham Nephrology Associates, Pa — Durham, North Carolina, United States
• Waterloo Dialysis — Austin, Texas, United States
• Fresenius North Austin Dialysis Center — Austin, Texas, United States
• Fresenius Kidney Care - Mission Bend (FMCNA #3971) — Houston, Texas, United States
• Fresenius Kidney Care Sugar Land — Sugar Land, Texas, United States
• Liberty Dialysis St. George — St. George, Utah, United States
• North America Research Institute - Azusa — Azusa, California, United States

Full record on ClinicalTrials.gov

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