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.
NCT ID NCT05175885
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation) 3. Recipients of an organ with any of the following characteristics: 1. Expected cold ischemia time before EVNP \> 20 hours 2. Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor 3. Organ with multiple arteries 4. Recipients with body mass index (BMI) \> 40 kg/m2 5. Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator. 6. Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at the moment of inclusion 7. Diagnosis of antiphospholipid syndrome at the moment of inclusion 8. Panel-reactive antibodies (PRA) score \> 50% 9. Known allergies to any of the components of the perfusate 10. Preexisting vascular disease that represents an extraordinary technical difficulty for the transplantation in the opinion of the investigator 11. Presence of clinically relevant donor-specific anti-HLA antibodies 12. ABO incompatibility 13. History of alcohol or drug abuse in the last two years 14. Use of normothermic regional perfusion during the organ harvesting process 15. Participation of the patient in another study or clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Miguel Servet University Hospital
RECRUITINGZaragoza, Zaragoza, Spain
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