RecruitingNot Applicable

Ex Vivo Normothermic Perfusion in Kidney Transplantation.

Spain100 participantsStarted 2023-12-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Two or more previous kidney transplantations
. Dual kidney transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation)
. Recipients of an organ with any of the following characteristics:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of EVNP in kidney transplantation from DCD and DBD donors as evaluated by assessment of adverse events

Timeframe: 1 year

Trial details

NCT IDNCT05175885

SponsorEbers Medical Technology, S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Pedro Moreo Calvo, PhD

+34 876 013 826 info@ebersmedical.com

View on ClinicalTrials.gov More Kidney Transplantation trials