End Stage Renal Disease (ESRD)OMNIPUMPNCT07920926
Hypothermic Kidney Machine Perfusion With Omnisol
A study testing Omnisol organ preservation solution in people with End Stage Renal Disease (ESRD) and Kidney Transplant, run by Vivalyx GmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Kidney Transplant, Kidney Failure
- What is being tested?
- Omnisol organ preservation solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Male or female, age > 18 years
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- 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
Who cannot join
- Donor kidneys accepted as a pair for dual transplant
- 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
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- 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
About this study
Official title: A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
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 detailed 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.
- Conditions
- End Stage Renal Disease (ESRD), Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures
- Being tested
- Omnisol organ preservation solution
- Keywords
- Hypothermic machine perfusion, Kidney preservation, Kidney transplantation
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnisol organ preservation solutionDevice
Omnisol for HMP of DBD or DCD donors.
| Study group | Role | What they receive |
|---|---|---|
| Donation after brain death (DBD) | Experimental | Recipients of a kidney from a donor after brain death (DBD). 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. Receives: Device: Omnisol organ preservation solution |
| Donation after circulatory death (DCD) | Experimental | Recipients of a kidney from a donor after circulatory 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. Receives: Device: Omnisol organ preservation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delayed Graft Function
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.
Measured: 7 days post-transplantation.
Graft Survival
30-day graft survival, censored and uncensored for recipient death.
Measured: 30 days post-transplantation.
Secondary outcomes (5)
Graft Survival
Graft survival, censored and uncensored for recipient death.
Measured: 3, 6 and 12 months post-transplantation.
Recipient Survival
Rate of recipient survival.
Measured: 30 days, 3, 6 and 12 months post-transplantation.
Kidney Graft Function
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI creatinine equation.
Measured: 30 days, 3, 6 and 12 months post-transplantation.
Primary Non-Function
Incidence of irreversible graft failure with no initial evidence of graft function following transplantation.
Measured: 30 days, 3, 6 and 12 months post-transplantation.
Duration of Delayed Graft Function
Duration of delayed graft function in participants who require renal replacement therapy after kidney transplantation.
Measured: 30 days post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivalyx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920926
- Sponsor's protocol ID
- OMNISOL_HMP_US
- Acronym
- OMNIPUMP
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
- ClinicalTrials.gov ID
- NCT07920926
- Acronym / sponsor ID
- OMNIPUMP / OMNISOL_HMP_US
- Conditions
- End Stage Renal Disease (ESRD), Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures
- Keywords
- Hypothermic machine perfusion, Kidney preservation, Kidney transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Vivalyx GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donation after brain death (DBD) | Experimental | Device: Omnisol organ preservation solutionRecipients of a kidney from a donor after brain death (DBD). 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. |
| Donation after circulatory death (DCD) | Experimental | Device: Omnisol organ preservation solutionRecipients of a kidney from a donor after circulatory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- Donor kidneys accepted as a pair for dual transplant
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnisol organ preservation solutionOmnisol for HMP of DBD or DCD donors. | Device | Donation after brain death (DBD), Donation after circulatory death (DCD) |
Primary outcome
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.
5 secondary outcomes
Graft Survival
Time frame: 3, 6 and 12 months post-transplantation.
Recipient Survival
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Kidney Graft Function
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Primary Non-Function
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Duration of Delayed Graft Function
Time frame: 30 days post-transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omnisol organ preservation solution in people with End Stage Renal Disease (ESRD) and Kidney Transplant, run by Vivalyx GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delayed Graft Function (time frame: 7 days post-transplantation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.