Renal failure Urological and Genital Diseases Renal failure
Conditions
Interventions
This study investigates the use of extended-duration normothermic machine perfusion (NMP) prior to transplantation of the kidney. This process involves circulating blood, oxygen and nutrients through
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day graft survival, defined as a functioning graft in a patient who does not require chronic dialysis, assessed clinically at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Graft survival, defined as a functioning graft in a patient who does not require chronic dialysis, assessed clinically at 3 and 12 months 2. Patient survival assessed clinically at 30 days, 3 months, 12 months 3. Use of dialysis in the first 7 days post-transplant, assessed as incidence (i.e. number who required dialysis / total number) and frequency (i.e. number of dialysis sessions required per time period), assessed clinically in the first 7 days post-transplant 4. Incidence of functional delayed graft function, defined as a failure of serum creatinine to fall by at least 10% per day for the first 3 days 5. Creatinine reduction ratio assessed using (serum creatinine day 2 - serum creatinine day 1) / serum creatinine day 1 on Day 2 6. Total proteinuria each day measured as milligrams of urinary protein by 24-hour urine collection on postoperative days 1-4 7. Total urine production assessed using 24-hour collection on postoperative days 1-4 8. Incidence of Primary Non-Function (PNF), defined as persistent dialysis dependence at 3 months post-transplant 9. eGFR assessed using CKD-EPI formula at 30 days, 3 months, and 12 months 10. Creatinine gradient assessed at month 12, using (serum creatinine month 12 - serum creatinine month 3) 11. Proteinuria as a binary variable defined using published KDIGO cut-offs and quantitated by protein-creatinine ratio, at 30 days, 3 months and 12 months 12. Incidence of acute rejection, defined as biopsy-proven acute rejection diagnosed in accordance with the Banff criteria at 12 months post-transplant 13. Histology assessed using Reummuzi scoring and KIM-1 immunohistochemistry pre-perfusion and post-reperfusion 14. Serial measurement of injury biomarkers including LDH and NGAL using biochemical assay on postoperative days 1-4 | — |
Countries
England, United Kingdom
Outcome results
None listed