Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
NCT07792317 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-08-28
Summary
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function.
Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.
Conditions
- Kidney Transplant
- Kidney Failure
- Renal and Urinary Tract Therapeutic Procedures
- End Stage Renal Disease (ESRD)
Interventions
- DEVICE
-
Omnisol organ preservation solution
Omnisol for HMP of deceased donor kidneys
Sponsors & Collaborators
-
Vivalyx GmbH
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-17
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Netherlands
Study Locations
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