Chronic Kidney Disease Clinical Trials

Find Chronic Kidney Disease Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Donor age \> 18 years

• Brain Death (DBD) or Circulatory Death \< 50 years (DCD\<50)

• Accepted for transplantation according to local criteria

• 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)

Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Benedict Doorschodt, MD
bd@vivalyx.com
+31 6 54658420
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2026-11
Participants
Target number of participants: 15
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Vivalyx GmbH

This content was sourced from clinicaltrials.gov