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RECRUITING
NCT07792317
NA

Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation

Sponsor: Vivalyx GmbH

View on ClinicalTrials.gov

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.

Official title: A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-11-17

Completion Date

2026-11

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DEVICE

Omnisol organ preservation solution

Omnisol for HMP of deceased donor kidneys

Locations (1)

Erasmus Medical Center

Rotterdam, Netherlands