Hosgood 2017

Trial name or title	Improving function of transplanted kidneys
Methods	UK‐based phase II multicentre RCT; not strictly paired
Participants	400 patients receiving a kidney from a DCD donor (categories III and IV, controlled) in the UK setting
Interventions	On arrival at the transplant centre, kidneys will be randomised to receive either normothermic MP (n = 200) or remain in SCS (n = 200). Kidneys undergoing normothermic MP will be perfused with an oxygenated packed red cell solution at near body temperature for 60 min prior to transplantation
Outcomes	DGF PNF: defined as the permanent lack of allograft function from the time of transplantation, including graft losses due to irreversible rejection and vascular thrombosis, is recorded along with the cause at the end of the study (12 months) Duration of DGF is measured by recording the number of sessions and days that the recipient requires dialysis after transplantation in days Functional DGF: defined as < 10% fall in SCr for 3 consecutive days, is measured using blood analysis in the first week post‐transplant CRR 2: creatinine day 1 – creatinine day 2/ creatinine day 1 is measured using blood analysis on day 2 CRR 5: pre transplant creatinine ‐ creatinine day 5/ pre‐transplant creatinine is measured using blood analysis on day 5 Length of hospital stay is measured as the number of days the recipient remains in hospital after the transplant Biopsy‐proven acute rejection rates are measured through examination of kidney biopsy samples when acute rejection is suspected SCr and eGFR is measured using blood and urine analysis at baseline (pre‐transplant), 1, 3, 6 and 12 months Patient survival (time from transplant to death) is measured in days Allograft survival (time from transplant to graft loss or return to dialysis) is measured in days
Starting date	01/03/2015
Contact information	Ms Sarah Hosgood Addenbrooke's Hospital Hills Road Cambridge CB2 0QQ United Kingdom
Notes	Estimated completion date 30/01/2021