An interventional study of Ex vivo normothermic perfusion and Cold preservation in Kidney Transplantation, sponsored by Ebers Medical Technology, S.L.. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Ebers Medical Technology, S.L. · Not applicable, Interventional, and Treatment
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.
The Ark Kidney is a medical device for ex vivo normothermic perfusion intended to create the conditions that allow kidneys to be resuscitated and / or preserved prior to transplantation. It consists of a permanent unit, which is retained after each perfusion, and a disposable circuit called the ARK Kidney Kidney Disposable Set (KDS), which must be replaced after perfusion to ensure sterile conditions.
It is a portable organ perfusion system designed to preserve a kidney by continuous perfusion of the donated organ with warm oxygenated perfusate supplemented with erythrocytes from the blood bank. The perfusion solution circulates continuously through the vascular network of the organ in a closed circuit. During perfusion, the system can monitor organ perfusion parameters, as well as the conditions of the perfusion solutions and the volume of urine generated during the perfusion.
The primary objective of the clinical study is to assess the viability, performance and safety of ex vivo normothermic perfusion with the Ark Kidney in kidney transplantation from DCD and DBD donors.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →This is the only study on the registry with Ebers Medical Technology, S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Recipients of an organ with any of the following characteristics:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ex vivo normothermic perfusion (EVNP) of the graft with the Ark Kidney System
Device: Ex vivo normothermic perfusion
Nonrandomized historical control group formed by patients transplanted without ex vivo normothermic perfusion (EVNP) in the period Sept 2015-Sept 2020, selected by retrospective matching.
Device: Cold preservation
Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System
Also known as: EVNP
Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft
Also known as: SCS/HMP
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
Delayed graft function (DGF)
Delayed graft function (DGF), defined as the need for dialysis during the first week after transplantation
Time frame: 1 week
Duration (in days) of delayed graft function (DGF)
Duration (in days) of delayed graft function (DGF)
Time frame: 1 month
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
Primary non-function (PNF)
Primary non-function (PNF)
Time frame: 1 week
Graft renal function (1 day)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 1 post-transplant in recipients who have not gone through dialysis after transplantation.
Time frame: 1 day
Graft renal function (3 days)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 3 post-transplant in recipients who have not gone through dialysis after transplantation.
Time frame: 3 days
Graft renal function (5 days)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 5 post-transplant in recipients who have not gone through dialysis in the previous three days.
Time frame: 5 days
Graft renal function (7 days)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 7 post-transplant in recipients who have not gone through dialysis in the previous three days.
Time frame: 7 days
Graft renal function (30 days)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 30 post-transplant in recipients who have not gone through dialysis in the previous three days.
Time frame: 30 days
Graft renal function (90 days)
Graft renal function, measured by the levels of serum creatinine and eGFR (CKD-EPI) at day 90 post-transplant in recipients who have not gone through dialysis in the previous three days.
Time frame: 90 days
Patient survival
Patient survival
Time frame: 1 year
Graft survival
Graft survival
Time frame: 1 year
Performance of EVNP in kidney transplantation from DCD and DBD donors as evaluated by the fraction of non-implanted organs because of the preservation method
The fraction of non-implanted organs will be compared in intervention arm and control arm
Time frame: 1 day
Viability of EVNP in kidney transplantation from DCD and DBD donors as evaluated by the ratio of planned vs. perfused organs
Viability of EVNP will be determined by the ratio of planned vs. perfused organs
Time frame: 1 day
Plan to share: No
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