NCT07792317

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 17, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Kidney TransplantKidney FailureRenal and Urinary Tract Therapeutic ProceduresEnd Stage Renal Disease (ESRD)

Keywords

Hypothermic machine perfusionKidney preservationKidney transplantation

Outcome Measures

Primary Outcomes (2)

  • Incidence of Delayed Graft Function

    Incidence of delayed graft function, defined as the need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalemia or volume overload.

    Within 7 days post-transplantation.

  • Graft Survival

    30-day graft survival (censored and uncensored for recipient death).

    30 days post-transplantation.

Secondary Outcomes (3)

  • Graft Survival

    3, 6 and 12 months post-transplantation.

  • Recipient survival

    30 days, 3, 6 and 12 months post-transplantation.

  • Kidney Graft Function Assessed by eGFR

    30 days, 3, 6 and 12 months post-transplantation.

Study Arms (1)

Hypothermic machine perfusion with Omnisol

EXPERIMENTAL

Prior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport.

Device: Omnisol organ preservation solution

Interventions

Omnisol organ preservation solutionDEVICE

Omnisol for HMP of deceased donor kidneys

Hypothermic machine perfusion with Omnisol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Listed for renal transplantation due to end stage renal disease on the Eurotransplant (ET) list
  • Fit to proceed with kidney transplantation (in opinion of investigator or deputy)
  • Donor kidneys accepted as a pair for dual transplant
  • Circulatory Death ≥ 50 years (DCD 50+)
  • Participation in an investigational study likely to affect interpretation of the trial data

You may not qualify if:

  • Breast-feeding or pregnant, as confirmed by pregnancy test or blood test, or plans to become pregnant over the study period
  • Participation in an investigational study likely to affect interpretation of the trial data
  • Mental disabilities that may affect the understanding of the study requirements including the ability to adhere to medication regime (in opinion of investigator or deputy)
  • Undergoing living donor kidney transplantation
  • Undergoing dual kidney transplantation
  • Undergoing transplantation of other organ(s) in addition to the kidney
  • Highly immunized patients with vPRA \> 85% (as confirmed by routine cross-matching test)
  • Other substantial risk of transplant not proceeding (in opinion of investigator or deputy)
  • Other significant disease or disorder which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) influence the result of the study; (iii) affect the participant's ability to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015, Netherlands

RECRUITING

MeSH Terms

Conditions

Renal InsufficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Benedict Doorschodt, MD

CONTACT

+31 6 54658420bd@vivalyx.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start

November 17, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations

NL(1)