The effect of the use of a TNF-alpha inhibitor in hypothermic machine perfusion on kidney function after transplantation.
Diuwe P, Domagala P, et al.Contemporary Clinical Trials 2017; 59: 44-50.
Aims
To assess the effect of the tumor necrosis factor-alpha (TNF-alpha) inhibitor etanercept on the machine perfusion hypothermia of renal allograft kidney function and organ perfusion.
Interventions
Paired kidneys were randomised, alternately (left/right) to either control, or to the intervention where the p75 Fc receptor protein (TNF-alpha inhibitor etanercept) was added to the perfusion fluid after the first hour of perfusion.
Participants
100 kidneys harvested from 50 deceased organ donors. 94 kidney recipients were transplanted with these organs.
Outcomes
The primary outcome measured was the difference in patient survival with functioning graft. Secondary measured outcomes included delayed graft function (DGF), functional DGF, acute rejection and kidney function.
Follow-up
12 – 39 months
CET Conclusions
This study investigated the effect of etanercept during hypothermic machine perfusion. The treatment had no significant effect on renal perfusion or survival. There was also no impact on DGF, which was very high in both treatment arms (72-76%) perhaps due to the long cold ischaemic times (26-29 hours). The method of randomisation was alternation of paired allocation, left kidney into one arm and right kidney into the other, so not truly random and the treatment was not blinded. No power calculation was presented so the study scores poorly on quality assessment.
Data analysis
Per protocol analysis
Trial registration
None