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

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