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.
Donor age > 18 years
Brain Death (DBD) or Circulatory Death < 50 years (DCD<50)
Accepted for transplantation according to local criteria
Male or female, age > 18 years
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
Single group
Omnisol organ preservation solution
DeviceOmnisol for HMP of deceased donor kidneys
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.
Graft Survival
30-day graft survival (censored and uncensored for recipient death).
Graft Survival
Graft survival (censored and uncensored for recipient death).
Recipient survival
Rate of recipient survival.
Kidney Graft Function Assessed by eGFR
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.
Click on the lead sponsor to view all of their trials.
