FDA -- Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop (September, 2011)

Last year FDA sponsored a public workshop of Ischemia Reperfusion Injury (IRI) and Downstream Effects on Long Term Outcomes in Kidney Transplant Recipients to facilitate and encourage the development of therapeutic modalities for the management of this condition and related indications. The workshop topics included, cellular and molecular mechanisms of IRI; utility of biomarkers for early IRI identification and long-term outcomes; agents for potential mitigation of IRI; animal models of IRI and DGF/SGF; the approval process for devices in kidney preservation; clinical trial designing, end points and study population (renal recipients).
Workshop Agenda
Workshop transcript Day 1
Workshop transcript Day 2