NCT07920926Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
Source: ClinicalTrials.gov · Last updated 6 Nov 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)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 30 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- May 2027
- Lead sponsor
- Vivalyx GmbH
- Diseases
- Chronic kidney disease
- NCT number
- NCT07920926
What you commit to
- Study type: Interventional
- Planned participants: 16
- From Jan 2027 to the primary completion date, May 2027
- No sites listed in no 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Donor kidneys accepted as a pair for dual transplant
- Exclusion for recipient:
- General exclusion criteria applicable to kidney transplantation
- 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 sensitized patients with cPRA > 80% (based on routine HLA antibody assessment)
- Other substantial risk of transplant not proceeding (in opinion of investigator or deputy)
Other illness
- 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
Other
- Exclusion for donor:
- 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
- Positive donor-specific crossmatch, if performed per institutional standard practice
Who the study is looking for
- Inclusion for donor:
- 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
- Inclusion for recipient:
- Male or female, age > 18 years
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.