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

Sponsor
Vivalyx GmbH
Study ID
NCT07792317
Status
Recruiting
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Conditions

  • End Stage Renal Disease (ESRD)
  • Kidney Failure
  • Kidney Transplant
  • Renal and Urinary Tract Therapeutic Procedures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omnisol organ preservation solution — DEVICE
    Omnisol for HMP of deceased donor kidneys

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Nov 17, 2025
Status verified
Aug 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hypothermic machine perfusion with Omnisol
    Prior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport.

Primary Outcome Measure

Incidence of Delayed Graft Function [ Time Frame: Within 7 days post-transplantation. ]

Central Contacts

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