Summary of FDA Workshop on Ischemia Reperfusion Injury in Kidney Transplantation

• Published in: American journal of transplantation Vol. 13; no. 5; pp. 1134 - 1148
• Main Authors: Cavaillé‐Coll, M., Bala, S., Velidedeoglu, E., Hernandez, A., Archdeacon, P., Gonzalez, G., Neuland, C., Meyer, J., Albrecht, R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Limited 01.05.2013
• Subjects: Animals; Clinical trials; Congresses as Topic; delayed graft function; Delayed Graft Function - etiology; efficacy; endpoints; Ischemia; ischemia reperfusion injury; Kidney Transplantation; Organ Preservation - methods; Reperfusion Injury - complications; safety; Transplants & implants; United States; United States Food and Drug Administration; United States
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/ajt.12210

The Food and Drug Administration (FDA) held an open public workshop in September 2011 to discuss the current state of science related to the effects of ischemia reperfusion injury (IRI) on outcomes in kidney transplantation. Topics included the development of IRI and delayed graft function (DGF), histology and biomarkers, donor factors, recipient factors, organ quality and organ preservation by means of cold storage solutions or machine perfusion. Various mechanisms of injury and maladaptive response to IRI were discussed as potential targets of intervention. Animal models evaluating specific pathophysiological pathways were presented, as were the limitations of extrapolating animal results to humans. Clinical trials of various drug products administered in the peri‐transplant period were summarized; a few demonstrated early improvements in DGF, but none demonstrated an improvement in late graft function. Clinical trial design for IRI and DGF were also discussed. The authors report on a public workshop sponsored by the FDA to discuss various topics related to the effects of ischemia reperfusion injury in kidney transplantation, and seek to guide the design of future clinical trials for the development of medical products to prevent or treat this condition.