Multicenter, Prospective and Open-label Clinical Trial to Evaluate the Viability, Performance and Safety of ex Vivo Normothermic Perfusion in Kidney Transplantation From DCD and DBD Donors.
A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.
• Patients aged 18 years and older
• Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective site.
• Candidates to receive a first or second renal transplant from (i) a Maastricht type III (Maastricht classification) controlled DCD donor or (ii) a DBD donor aged 70 years or older.
• Patients that have given informed consent in written form before their inclusion in the study. In case of compromised mental capacity, the approval and signature of a legal guardian will be required.
• Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study.
• Patients that meet the acceptance criteria for kidney transplant recipients established in the clinical site in agreement with usual clinical practice.