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

A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure; End Stage Renal Disease (ESRD); Kidney Transplant; Renal and Urinary Tract Therapeutic Procedures
• Intervention / Treatment: Device: Omnisol organ preservation solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benedict Doorschodt, MD; Phone Number: +31 6 54658420; Email: bd@vivalyx.com

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015
    • Recruiting
    • Erasmus Medical Center
    • Contact: Robert Minnee, MD PhD; Phone Number: +31-10-70 31149; Email: r.minnee@erasmusmc.nl
    • Principal Investigator: Robert Minee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Omnisol for HMP of deceased donor kidneys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days post-transplantation.
Graft Survival	30-day graft survival (censored and uncensored for recipient death).	30 days post-transplantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Survival	Graft survival (censored and uncensored for recipient death).	3, 6 and 12 months post-transplantation.
Recipient survival	Rate of recipient survival.	30 days, 3, 6 and 12 months post-transplantation.
Kidney Graft Function Assessed by eGFR	Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.	30 days, 3, 6 and 12 months post-transplantation.

Collaborators and Investigators

• Sponsor: Vivalyx GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Kidney transplantation; Hypothermic machine perfusion; Kidney preservation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: OMNISOL_HMP_NL; NL-OMON57467 (Other Identifier: Overview of Medical Research in the Netherlands (OMON)); NL87460.000.24 (Other Identifier: The Central Committee on Research Involving Human Subjects (CCMO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No