PROlonged ex-vivo normothermic machine PERfusion for kidney regeneratio
Phase 2
Recruiting
- Conditions
- kidney transplantation1002914910038365
- Registration Number
- NL-OMON52366
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Adult patients undergoing a kidney transplantation in LUMC (Leiden) or UMCG
(Groningen) will be included in this study. Only donor kidneys from Maastricht
Type III and V (controlled) donors after circulatory death (DCD, n=18) will be
included. Recipient criteria include any single organ first renal transplant at
a participating centre.
Exclusion Criteria
Recipients of second or subsequent, ABO/HLA incompatible transplants and highly
sensitised patients will be excluded. Kidneys with a cold ischaemia time >12
hours at the point of arrival at the transplant centre will be excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary clinical outcome will be safety of PNMP of DCD kidneys up to 6<br /><br>hours, defined as absence of SUSARs and at least similar secondary outcomes at<br /><br>1 month post transplantation as those expected from kidney transplants with<br /><br>similar donor and recipient characteristics, based on historical matched<br /><br>cohort.</p><br>
- Secondary Outcome Measures
Name Time Method