NCT05175885 Ex Vivo Normothermic Perfusion in Kidney Transplantation.
| NCT ID | NCT05175885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ebers Medical Technology, S.L. |
| Condition | Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2025-12 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 years and older 2. Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective site. 3. 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. 4. 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. 5. Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study. 6. Patients that meet the acceptance criteria for kidney transplant recipients established in the clinical site in agreement with usual clinical practice. Exclusion Criteria: 1. Two or more previous kidney transplantations 2. Dual kidney transplanta
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