Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD) · Kidney Transplant · Kidney Failure · Renal and Urinary Tract Therapeutic Procedures
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 16 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
Hypothermic machine perfusion (HMP) is increasingly used for the preservation of deceased donor kidneys before transplantation. Omnisol was developed as an extracellular-type organ preservation solution for the flushing and HMP of donor kidneys.
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.
This prospective, single-center, non-randomized clinical investigation is designed primarily to evaluate the safety of Omnisol when used for the wash-out and HMP of kidneys from deceased donors before transplantation. The investigation incorporates a retrospective matched-control design, where each recipient of a kidney preserved with Omnisol will be matched with two recipients previously transplanted at the same center with kidneys preserved by HMP using UW-MPS.
This study employs a back-to-base design, meaning that after arrival at the transplant center according to standard of care, the kidney is flushed with Omnisol and transferred to HMP using Omnisol in the standard of care perfusion machine until implantation.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Hypothermic machine perfusion with Omnisol
Recipients of a kidney from a donor after brain death (DBD) or a donor after cardiac death (DCD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation.
Device: Omnisol organ preservation solution
Omnisol organ preservation solution DEVICE
Omnisol for HMP of DBD or DCD donors.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of Delayed Graft Function
Time frame: 7 days post-transplantation.
Incidence of delayed graft function, defined as the requirement for at least one dialysis session within the first 7 days after transplantation, excluding a single dialysis session performed solely for hyperkalemia or volume overload.
Graft Survival
Time frame: 30 days post-transplantation.
30-day graft survival, censored and uncensored for recipient death.
Secondary measures
Graft Survival
Time frame: 3, 6 and 12 months post-transplantation.
Graft survival, censored and uncensored for recipient death.
Recipient Survival
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Rate of recipient survival.
Kidney Graft Function
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI creatinine equation.
Primary Non-Function
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Incidence of irreversible graft failure with no initial evidence of graft function following transplantation.
Duration of Delayed Graft Function
Time frame: 30 days post-transplantation.
Duration of delayed graft function in participants who require renal replacement therapy after kidney transplantation.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Vivalyx GmbH
- Study start
- 2027-01 Estimated
- Primary completion
- 2027-05 Estimated
- Study completion
- 2028-05 Estimated
- First posted
- Nov 6, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026