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RecruitingNCT07792317NEWHOPEUpdated Aug 28, 2026

Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation

An interventional study of Omnisol organ preservation solution in Kidney Transplant, Kidney Failure and Renal and Urinary Tract Therapeutic Procedures, sponsored by Vivalyx GmbH. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Primary conditionKidney Failure, ChronicRegistry: Renal InsufficiencyReclassifiedWhy we changed it
Registry
Renal Insufficiency — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Failure, Chronic
Why
  1. The study's listed conditions name Kidney Failure, Chronic, a narrower term within Renal Insufficiency.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Vivalyx GmbH · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2025, registered Aug 2026).
  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Kidney Transplant
  • Kidney Failure
  • Renal and Urinary Tract Therapeutic Procedures
  • End Stage Renal Disease (ESRD)

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Keywords

  • Hypothermic machine perfusion
  • Kidney preservation
  • Kidney transplantation
03

In context

Kidney Failure, Chronic Reclassified

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 15 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Vivalyx GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Hypothermic machine perfusion with Omnisol

    Prior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport.

    Device: Omnisol organ preservation solution

Interventions

  • DeviceOmnisol organ preservation solution

    Omnisol for HMP of deceased donor kidneys

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 7 days post-transplantation.

  2. Graft Survival

    30-day graft survival (censored and uncensored for recipient death).

    Time frame: 30 days post-transplantation.

Secondary outcomes

  1. Graft Survival

    Graft survival (censored and uncensored for recipient death).

    Time frame: 3, 6 and 12 months post-transplantation.

  2. Recipient survival

    Rate of recipient survival.

    Time frame: 30 days, 3, 6 and 12 months post-transplantation.

  3. Kidney Graft Function Assessed by eGFR

    Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.

    Time frame: 30 days, 3, 6 and 12 months post-transplantation.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

Of 78 industry-sponsored interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 12 months is below that.

Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 28, 2026
StartActual
Nov 17, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07792317
Lead sponsor
Vivalyx GmbH
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Nov 17, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Aug 28, 2026

Study contacts

Benedict Doorschodt, MD
Contact
bd@vivalyx.com
+31 6 54658420

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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