Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, single-center, open-label study evaluating Omnisol as an organ preservation solution for continuous hypothermic machine perfusion of deceased donor kidneys prior to transplantation. The trial uses a non-randomized, uncontrolled design to assess safety and potential improvements in graft function with Omnisol compared to standard solutions. Adult recipients listed for kidney transplantation who receive a kidney preserved with Omnisol are followed to monitor graft performance and adverse events. The study leverages the XVIVO Kidney Assist Transport system for preservation in a Dutch center. Primary outcomes focus on early graft function and safety signals related to the preservation method.

Why it matters

Who can join: the full rules

Inclusion for donor:

* Donor age \> 18 years
* Brain Death (DBD) or Circulatory Death \< 50 years (DCD\<50)
* Accepted for transplantation according to local criteria

Inclusion for recipient:

* Male or female, age \> 18 years
* Able and willing to comply with all study requirements (in opinion of investigator or deputy)
* General inclusion criteria applicable to kidney transplantation:

  * 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)

Exclusion for donor:

* 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

Exclusion for recipient:

* General exclusion criteria applicable to kidney transplantation
* 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

Where it's running

• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Benedict Doorschodt, MD
• Email: bd@vivalyx.com
• Phone: +31 6 54658420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.