Study to Evaluate Safety and Performance of the Ark Kidney Device Using Ex Vivo Normothermic Perfusion in Kidney Transplants from DCD and Older DBD Donors

What this Trial Is About

Researchers are evaluating the safety, performance, and viability of ex vivo normothermic perfusion EVNP in kidney transplantation using the Ark Kidney device. This study focuses on kidneys donated from controlled donation after circulatory death DCD and donation after brain death DBD donors, aiming to improve preservation and resuscitation before transplantation. The Ark Kidney system is a portable device that continuously perfuses the donated kidney with warm oxygenated blood supplemented with erythrocytes. It includes a permanent unit and a disposable circuit replaced after each use to maintain sterility. The study compares the EVNP method with a historical control group of patients who received kidneys preserved by traditional cold methods. During perfusion, the system monitors parameters such as perfusion conditions and urine output. Participants will undergo kidney transplantation with monitoring for safety and function over the course of one year. Researchers will assess adverse events, delayed graft function, graft survival, and patient survival, among other measures. Follow-up includes evaluation of kidney function at several time points up to 90 days and longer-term outcomes at one year.

Ex Vivo Normothermic Perfusion in Kidney Transplantation.