Normothermic Kidney Preservation Phase 1 (NKP1)
The Phase 1 Normothermic Kidney Preservation Study (NKP1) is a first-in-man study investigating the use of a novel normothermic preservation device for kidney transplantation. The device, developed by OrganOx, perfuses a donor kidney outside the body with oxygenated blood at body temperature, allowing the surgical team to assess function before transplant.
The Phase 1 study will recruit 36 kidneys, gradually increasing the duration of preservation up to 24 hours prior to transplant. The study aims to demonstrate safety of the device, and provide information for a future larger phase 3 trial.
The study is funded by a grant from the NIHR i4i scheme. It opened to recruitment in December 2021.