chronic kidney faillure, renal failure chronic kidney faillure, renal failure
Conditions
Interventions
Omnisol is an extracellular-type organ preservation solution. As an organ preservation solution, Omnisol supports the maintenance of the structural and functional integrity of the organ and intends to
Sponsors
Vivalyx GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion for donor:Donor age > 18 yearsBrain Death (DBD) or Circulatory Death < 50 years (DCD<50)Accepted for transplantation according to local criteriaInclusion for recipient:Male or female, age > 18 yearsAble 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) listFit to proceed with kidney transplantation (in opinion of investigator or deputy)
Exclusion criteria
Exclusion criteria: Exclusion for donor:Donor kidneys accepted as a pair for dual transplantCirculatory Death = 50 years (DCD 50+)Participation in an investigational study likely to affect interpretation of the trial dataExclusion for recipient:General exclusion criteria applicable to kidney transplantationBreast-feeding or pregnant, as confirmed by pregnancy test or blood test, or plans to become pregnant over the study periodParticipation in an investigational study likely to affect interpretation of the trial dataMental 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 transplantationUndergoing dual kidney transplantationUndergoing transplantation of other organ(s) in addition to the kidneyHighly 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of delayed graft function (DGF), defined as the need for dialysis within the first week post-transplant, excluding 1-time dialysis for hyperkalaemia or volume overload30-day graft survival (censored and uncensored for recipient death) | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-month, 6-month and 12-month graft survival (censored and uncensored for recipient death)30 day, 3-month and, 6-month and 12-month recipient survivalGraft function, defined as the estimated glomerular filtration (eGFR) rate at 30 days, 3 months, 6 months and 12 months post-transplant | — |
Countries
Netherlands
Contacts
Public ContactM. Brinkhof
BeVinced
Outcome results
None listed