Kidney TransplantNEWHOPENCT07792317
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
A study testing Omnisol organ preservation solution in people with Kidney Transplant and Kidney Failure, run by Vivalyx GmbH at 1 site in Netherlands.
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
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures
- 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
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2025to Nov 2026
- 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 < 50 years (DCD<50)
- Accepted for transplantation according to local criteria
- 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)
Who cannot join
- 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
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015
Robert Minnee, MD PhD, +31-10-70 31149, r.minnee@erasmusmc.nl
Robert Minee
About this study
Official title: A Single-center, Non-randomized, Uncontrolled Pilot 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
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.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Being tested
- Omnisol organ preservation solution
- Keywords
- Hypothermic machine perfusion, Kidney preservation, Kidney transplantation
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
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 deceased donor kidneys
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic machine perfusion with Omnisol | Experimental | Prior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport. 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 need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalemia or volume overload.
Measured: Within 7 days post-transplantation.
Graft Survival
30-day graft survival (censored and uncensored for recipient death).
Measured: 30 days post-transplantation.
Secondary outcomes (3)
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 Assessed by eGFR
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.
Measured: 30 days, 3, 6 and 12 months post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start17 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT07792317
- Sponsor's protocol ID
- OMNISOL_HMP_NL
- Other IDs
- NL-OMON57467, NL87460.000.24
- Acronym
- NEWHOPE
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
- ClinicalTrials.gov ID
- NCT07792317
- Acronym / sponsor ID
- NEWHOPE / OMNISOL_HMP_NL
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Keywords
- Hypothermic machine perfusion, Kidney preservation, Kidney transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vivalyx GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Aug 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermic machine perfusion with Omnisol | Experimental | Device: Omnisol organ preservation solutionPrior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Donor age > 18 years
- Brain Death (DBD) or Circulatory Death < 50 years (DCD<50)
- Accepted for transplantation according to local criteria
- Male or female, age > 18 years
- Able and willing to comply with all study requirements (in opinion of investigator or deputy)
Key exclusion criteria (13 listed)
- 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
- 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
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 deceased donor kidneys | Device | Hypothermic machine perfusion with Omnisol |
Primary outcome
Incidence of Delayed Graft Function
Time frame: 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
Time frame: 30 days post-transplantation.
30-day graft survival (censored and uncensored for recipient death).
3 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 Assessed by eGFR
Time frame: 30 days, 3, 6 and 12 months 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 28 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnisol organ preservation solution in people with Kidney Transplant and Kidney Failure, run by Vivalyx GmbH at 1 site in Netherlands.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Benedict Doorschodt, MD (+31 6 54658420, bd@vivalyx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delayed Graft Function (time frame: Within 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 28 Aug 2026.