A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation.Kaabak M, Babenko N, et al.
Pediatr Transplant 2018 [record in progress].
To determine whether Eculizumab is an effective agent in the prevention or amelioration of Ischemia-reperfusion injury (IRI) in paediatric kidney transplant recipients.
Patients were randomized to either an intervention group and received eculizumab 700 mg/m2, administered intravenously over one hour after admission to the hospital, versus control group.
57 paediatric kidney transplant recipients aged ≤ 18 years.
Primary measured outcomes included initial graft function and delayed graft function. Secondary measured outcomes included patient and graft survival, rejection, renal function and the banff scores of graft biopsies.
This is a well conducted and written study that scores moderately on quality assessment. The study was adequately randomised, however it was not blinded after allocation when this could have been possible. The initial graft function (a composite of measures) was not different between groups. EGFR on days 1 and 2 was significantly better in the Eculizumab group. Graft and one-year survival was not different between groups. Importantly there were 4 early graft losses in the Eculizumab group, during a flu-like infection that resulted in renal vein thrombosis in unvaccinated children. There was a reduction in DGF (0 versus 38% in deceased donors) with Eculizumab, but this outcome has not been statistically assessed and we suspect it is not statistically significant, given the small numbers included. There was no difference in acute rejection rate. It is unclear whether any power calculation was done to design the study, and this is possibly why it is small in number and no great differences can be seen between groups. The substantial immune suppression at the time of transplantation in this study seems to have had an overall negative impact through graft loss, although there was an improvement in early graft function in the first 2 days.
ClinicalTrials.gov - NCT1756508