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

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

Delayed Graft Function

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Miguel Servet University Hospital

    RECRUITING

    Zaragoza, Zaragoza, Spain

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