An interventional study of Omnisol organ preservation solution in End Stage Renal Disease (ESRD), Kidney Transplant and Kidney Failure, sponsored by Vivalyx GmbH. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Vivalyx GmbH · Not applicable, Interventional, and Treatment
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.
Hypothermic machine perfusion (HMP) is increasingly used for the preservation of deceased donor kidneys before transplantation. Omnisol was developed as an extracellular-type organ preservation solution for the flushing and HMP of donor kidneys.
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.
This prospective, single-center, non-randomized clinical investigation is designed primarily to evaluate the safety of Omnisol when used for the wash-out and HMP of kidneys from deceased donors before transplantation. The investigation incorporates a retrospective matched-control design, where each recipient of a kidney preserved with Omnisol will be matched with two recipients previously transplanted at the same center with kidneys preserved by HMP using UW-MPS.
This study employs a back-to-base design, meaning that after arrival at the transplant center according to standard of care, the kidney is flushed with Omnisol and transferred to HMP using Omnisol in the standard of care perfusion machine until implantation.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 16 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Vivalyx GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion for donor:
Inclusion for recipient:
Exclusion Criteria:
Exclusion for donor:
Exclusion for recipient:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recipients of a kidney from a donor after brain death (DBD) or a donor after cardiac death (DCD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation.
Device: Omnisol organ preservation solution
Omnisol for HMP of DBD or DCD donors.
Incidence of Delayed Graft Function
Incidence of delayed graft function, defined as the requirement for at least one dialysis session within the first 7 days after transplantation, excluding a single dialysis session performed solely for hyperkalemia or volume overload.
Time frame: 7 days post-transplantation.
Graft Survival
30-day graft survival, censored and uncensored for recipient death.
Time frame: 30 days post-transplantation.
Graft Survival
Graft survival, censored and uncensored for recipient death.
Time frame: 3, 6 and 12 months post-transplantation.
Recipient Survival
Rate of recipient survival.
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Kidney Graft Function
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI creatinine equation.
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Primary Non-Function
Incidence of irreversible graft failure with no initial evidence of graft function following transplantation.
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Duration of Delayed Graft Function
Duration of delayed graft function in participants who require renal replacement therapy after kidney transplantation.
Time frame: 30 days post-transplantation.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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