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NCT07920926
Hypothermic Kidney Machine Perfusion With Omnisol
Conditions: End Stage Renal Disease (ESRD), Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Vivalyx GmbH
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Inclusion for donor:
* Donor age \> 18 years
* Brain Death (DBD) or Circulatory Death (DCD)
* Accepted for transplantation according to local criteria
* For DCD donors: functional warm ischemia time (WIT) ≤ 30 minutes and total WIT ≤ 60 minutes
* Cold ischemia time (CIT) prior to HMP with Omnisol no greater than 14 hours
Inclusion for recipient:
* Male or female, age \> 18 years
* Able and willing to provide informed consent and 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 OPO list
* Able and willing to comply with all study requirements (in opinion of investigator or deputy)
* Fit to proceed with kidney
Exclusion Criteria:
Exclusion for donor:
• Donor kidneys accepted as a pair for dual transplant
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 sensitized patients with cPRA \> 80% (based on routine HLA antibody assessment)
* Positive donor-specific crossmatch, if performed per institutional standard practice
* 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
Source: ClinicalTrials.gov (NCT07920926). StuddyBuddy aggregates publicly available trial information.