Transplant Trial Watch

Graft Pre-conditioning by Peri-Operative Perfusion of Kidney Allografts With Rabbit Anti-human T-lymphocyte Globulin Results in Improved Kidney Graft Function in the Early Post-transplantation Period-a Prospective, Randomized Placebo-Controlled Trial.

Ritschl PV, Gunther J et al.

Front. 2018; 9:1911.


Aims
A single-blinded, randomized trial to determine whether peri-operative perfusion of renal transplants with anti-human T-lymphocyte globulin (ATLG) reduces ischemia reperfusion injury and results in improved graft function.

Interventions
Prior to implantation, organs were perfused and incubated with ATLG (AP; n=24 kidney). Control organs were perfused with saline only (CP; n=26 kidney).

Participants
50 kidney transplant recipients (adults receiving a kidney from deceased donors) were included and randomly assigned 1:1.

Outcomes
Primary endpoints were change in graft function (eGFR and serum urea for KT recipients) at day 7 from baseline. Key secondary endpoints were graft function and patient survival. Biopsies were taken 1 hour after reperfusion. Blood samples were collected from recipients at pre- (day−1) and post transplantation (POD 0, 1, 3, 5, 7, 10, 15, months 3, 6 and 12). Primary analysis was performed in the ITT population. Missing data for the primary analysis of longitudinal clinical parameters (percentage of change from baseline prior to transplantation) were not imputed.

Follow-up
12 months

CET Conclusions
This study investigates the role of ex-vivo perfusion with rabbit ATG in reducing ischaemia reperfusion injury following renal transplantation. Kidneys were randomised to perfusion with saline or rATG prior to flush and implantation. The rATG group demonstrated improved serum creatinine levels in the 2-weeks post-transplant, with numerically lower rates of DGF, although the small sample size means that this did not reach significance. No difference in function was seen at 12 months. Whilst interesting, there are some methodological issues. No sample size calculation is presented, and the sample size is small (particularly at 12 months follow-up). Perfusion with saline in the control group is not standard practice and may in fact increase the risk of ischemia reperfusion injury compared to storage in a conventional perfusion solution. The small sample size leads to an imbalance in important characteristics between the groups in favour of the rATG group, including proportion of ECD kidneys (33% vs 50%) and cold and ward ischaemia (although none of these reach significance). Further, larger studies are required to confirm the findings presented here.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT03377283

Funding source
Industry & non-industry funded