NCT07792317Recruiting
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 17 Nov 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Vivalyx GmbH
- Diseases
- Chronic kidney disease
- NCT number
- NCT07792317
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 17 Nov 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.