Investigation of the safety and feasibility of preservation of kidneys for up to 24 hours at normal body temperature prior to transplant

Not Applicable

Completed

• Conditions: Renal failure; Urological and Genital Diseases

• Registration Number: ISRCTN13292277
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Study Completion: 2024-01-12
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Donor criteria:
1. Kidneys from deceased donors aged above 16 years
2. DCD or DBD
3. Accepted for transplantation according to local criteria
4. Cold ischaemia time (CIT) prior to NMP no greater than 10 hours

Recipient criteria:
1. Male or female, aged 18 years or older
2. On waiting list for kidney transplantation at Oxford Transplant Centre, Oxford
3. Provided informed consent for participation in the study
4. Able and willing to comply with all study requirements (in opinion of investigator or deputy)
5. Fit to proceed with kidney transplantation

Matched controls criteria:
1. Kidneys from donors aged 16 years or over
2. DBD or DCD
3. Recipients underwent transplantation of a deceased-donor kidney on or after 01/10/2016

Exclusion Criteria

Donor criteria:
1. Donor kidneys that would not be accepted according to local criteria
2. Donor kidneys accepted as a pair for dual transplant
3. CIT greater than 10 hours prior to initiation of NMP

Recipient criteria:
1. Not willing or unable to provide informed consent
2. Recipients aged less than 18 years
3. Participation in an investigational study likely to affect on interpretation of the trial data
4. Undergoing living donor kidney transplantation
5. Undergoing dual kidney transplantation
6. Undergoing transplantation of other organ(s) in addition to the kidney
7. Substantial risk of transplant not proceeding – e.g. risk of positive cross-match (in opinion of Investigator and/ or implanting surgeon)
8. 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

Matched controls criteria:
1. Underwent transplantation of other organ(s) in addition to the kidney
2. Underwent dual kidney transplantation
3. Underwent living donor kidney transplantation
4. 12-month eGFR not available

Study & Design

• Study Type: Interventional
• Study Design: Not specified