Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

• speed of the graft warming [ Time Frame: at the time of engraftment ] [ Designated as safety issue: No ]
  The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.
  
  
• initial graft function [ Time Frame: first week after Tx ] [ Designated as safety issue: No ]

  initial graft function will be accessed daily during the first week post Tx and measured as follows:

  • the rate of serum creatinine decrease expressed as percent per day, where 100% will be the creatinine on the day before;
  • intragraft blood flow by Doppler indexes (acceleration, resistance) and blood flow velocity on the three levels - main, interlobar and arcuate arteries;
  
  

• graft morphology changes [ Time Frame: one year after transplantation ] [ Designated as safety issue: No ]
  Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.
  
  
• One-year graft and patient survival, as well as rejection and infection rates will be calculated [ Time Frame: one year after Tx ] [ Designated as safety issue: Yes ]
  

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.