Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Recruiting · NCT07792317 · Interventional (participants receive a specific treatment) · Lead sponsor: Vivalyx GmbH
View the official record on ClinicalTrials.gov →Interventions studied
Omnisol organ preservation solution
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Erasmus Medical Center - Rotterdam, Netherlands