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Can a new preservation fluid keep donor kidneys healthier for transplant?

NCT ID NCT07792317

Disease control Sponsor: Vivalyx GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This pilot study tests whether Omnisol, a new preservation solution, can keep deceased donor kidneys in better condition during machine perfusion before transplantation. The goal is to reduce delayed graft function, where the kidney takes time to start working, and improve early graft survival. Researchers will enroll 15 kidney transplant recipients and track outcomes like the need for dialysis in the first week and kidney function at 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omnisol organ preservation solution
What this could lead to
If Omnisol preserves donor kidneys better than current solutions, it could reduce delayed graft function and improve early transplant outcomes, potentially expanding the usable donor organ pool.
What could go wrong
This is a small pilot study with only 15 participants, so results may not apply broadly. The solution might not outperform existing options, and there are inherent risks in organ transplantation, such as graft failure or rejection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End stage renal disease (ESRD) Kidney failure Kidney transplant Renal and urinary tract therapeutic procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, 3015, Netherlands

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