Health TrialsbyHealthPanel

Ex Vivo Normothermic Perfusion in Kidney Transplantation.

ConditionKidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEbers Medical Technology, S.L.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Two or more previous kidney transplantations

Dual kidney transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation)

Expected cold ischemia time before EVNP > 20 hours

Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ex vivo normothermic perfusion

    Device

    Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System

  • Cold preservation

    Device

    Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Historical control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

The rate of adverse events will be compared in intervention arm and control arm

Time frame
1 year

Secondary outcomes

1

Delayed graft function (DGF)

Delayed graft function (DGF), defined as the need for dialysis during the first week after transplantation

Time frame
1 week
2

Duration (in days) of delayed graft function (DGF)

Duration (in days) of delayed graft function (DGF)

Time frame
1 month
3

Proportion of patients with functional delayed graft function (fDGF)

Proportion of patients with functional delayed graft function (fDGF), defined as the failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days during the first week post-transplant, without need for dialysis in that time.

Time frame
1 week
4

Primary non-function (PNF)

Primary non-function (PNF)

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ebers Medical Technology, S.L.

Lead sponsor

Source ClinicalTrials.gov
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