Status:
UNKNOWN
PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
Lead Sponsor:
Leiden University Medical Center
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
Detailed Description
Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient wit...
Eligibility Criteria
Inclusion
- Patients undergoing 1st or 2nd kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht III \& V
- Transplant recipients aged ≥ 18 years
- Written informed consent
Exclusion
- Patients undergoing 3rd or subsequent kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht I, II \& IV
- Transplant recipients aged \< 18 years
- Patients receiving multi-organ transplants
- ABO/HLA incompatible transplants
- Highly sensitized patients with a panel-reactive antibody (PRA) ≥85%
- Kidneys with CIT \> 12 hrs at the point of arrival at transplant centre
- Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder)
- Kidneys explanted from a donor on normothermic regional perfusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04693325
Start Date
December 1 2021
End Date
January 1 2023
Last Update
January 3 2022
Active Locations (2)
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1
University Medical Center Groningen
Groningen, Netherlands
2
Leiden University Medical Center
Leiden, Netherlands