Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Public ClinicalTrials.gov record NCT04523220. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04523220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 704 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2020 (Actual)
- Primary completion
- Dec 28, 2021 (Actual)
- Completion
- May 30, 2022 (Actual)
- Last update posted
- Jul 21, 2023
2020 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North America Research Institute - Azusa | Azusa | California | 91702 | — |
| Fresenius Kidney Care - Brawley | Brawley | California | 92227 | — |
| DaVita South Valley Dialysis | Encino | California | 91316 | — |
| Fresenius Kidney Care - La Mesa | La Mesa | California | 91942 | — |
| East L.A. Dialysis Center | Los Angeles | California | 90022 | — |
| Van Buren Dialysis Center | Riverside | California | 92503 | — |
| Fresenius Kidney Care Kearny Mesa | San Diego | California | 92111 | — |
| FMC San Ysidro | San Diego | California | 92154 | — |
| Queen's Dialysis Unit | West Covina | California | 91790 | — |
| DaVita Greater Waterbury Dialysis | Waterbury | Connecticut | 06708 | — |
| ARA Plantation Dialysis, LLC | Ellenton | Florida | 34222 | — |
| ARA Augusta | Augusta | Georgia | 30901 | — |
| Liberty Dialysis- Caldwell | Caldwell | Idaho | 83605 | — |
| Fresenius Kidney Care Evergreen Park | Evergreen Park | Illinois | 60805 | — |
| Fresenius Kidney Care Baton Rouge Mancuso Lane | Baton Rouge | Louisiana | 70808 | — |
| Fresenius Kidney Care South Dialysis | Shreveport | Louisiana | 71106 | — |
| ARA Holyoke Dialysis Center | Holyoke | Massachusetts | 01040 | — |
| Davita Hospital Hill Dialysis | Kansas City | Missouri | 64108 | — |
| Renal Medicine Associates | Albuquerque | New Mexico | 87109 | — |
| Durham Nephrology Associates, Pa | Durham | North Carolina | 27704 | — |
| Waterloo Dialysis | Austin | Texas | 78756 | — |
| Fresenius North Austin Dialysis Center | Austin | Texas | 78758 | — |
| Fresenius Kidney Care - Mission Bend (FMCNA #3971) | Houston | Texas | 77083 | — |
| Fresenius Kidney Care Sugar Land | Sugar Land | Texas | 77479 | — |
| Liberty Dialysis St. George | St. George | Utah | 84790 | — |
| DaVita Butler Farm Dialysis | Hampton | Virginia | 23666 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 125 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04523220, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2023 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04523220 live on ClinicalTrials.gov.