End Stage Renal Disease (ESRD), Kidney Failure, Kidney Transplant, Renal and Urinary Tract Therapeutic Procedures
Conditions
Keywords
Hypothermic machine perfusion, Kidney preservation, Kidney transplantation
Brief 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.
Detailed description
Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion. Continuous HMP using the XVIVO Kidney Assist Transport is routinely used for deceased donor kidney preservation in the Netherlands. This is a single-center, non-randomized, uncontrolled, open-label first-in-human clinical investigation evaluating Omnisol as an organ preservation solution for continuous HMP of deceased donor kidneys before transplantation.
Interventions
DEVICEOmnisol organ preservation solution
Omnisol for HMP of deceased donor kidneys
Sponsors
Vivalyx GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delayed Graft Function | Within 7 days post-transplantation. | 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 days post-transplantation. | 30-day graft survival (censored and uncensored for recipient death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Survival | 3, 6 and 12 months post-transplantation. | Graft survival (censored and uncensored for recipient death). |
| Recipient survival | 30 days, 3, 6 and 12 months post-transplantation. | Rate of recipient survival. |
| Kidney Graft Function Assessed by eGFR | 30 days, 3, 6 and 12 months post-transplantation. | Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula. |
Countries
Netherlands
Contacts
CONTACTBenedict Doorschodt, MD
Outcome results
None listed