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

Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion.

Continuous HMP using the XVIVO Kidney Assist Transport is routinely used for deceased donor kidney preservation in the Netherlands.

This is a single-center, non-randomized, uncontrolled, open-label first-in-human clinical investigation evaluating Omnisol as an organ preservation solution for continuous HMP of deceased donor kidneys before transplantation.

• Omnisol organ preservation solution (Device): Omnisol for HMP of deceased donor kidneys

Primary outcomes

• Incidence of Delayed Graft Function [Within 7 days post-transplantation.]: 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.
• Graft Survival [30 days post-transplantation.]: 30-day graft survival (censored and uncensored for recipient death).

Secondary outcomes

• Graft Survival [3, 6 and 12 months post-transplantation.]: Graft survival (censored and uncensored for recipient death).
• Recipient survival [30 days, 3, 6 and 12 months post-transplantation.]: Rate of recipient survival.
• Kidney Graft Function Assessed by eGFR [30 days, 3, 6 and 12 months post-transplantation.]: Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.

Sex: All, ages: 18 Years to any

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