Kidney TransplantationKidneyARKNCT05175885
Ex Vivo Normothermic Perfusion in Kidney Transplantation.
A study testing Ex vivo normothermic perfusion and Cold preservation in people with Kidney Transplantation, run by Ebers Medical Technology, S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Ex vivo normothermic perfusion and Cold preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 14 Dec 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Expected cold ischemia time before EVNP > 20 hours
- Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor
- Organ with multiple arteries
Show all 18Show fewer
- Recipients with body mass index (BMI) > 40 kg/m2
- Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator.
- Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at the moment of inclusion
- Diagnosis of antiphospholipid syndrome at the moment of inclusion
- Panel-reactive antibodies (PRA) score > 50%
- Known allergies to any of the components of the perfusate
- Preexisting vascular disease that represents an extraordinary technical difficulty for the transplantation in the opinion of the investigator
- Presence of clinically relevant donor-specific anti-HLA antibodies
- ABO incompatibility
- History of alcohol or drug abuse in the last two years
- Use of normothermic regional perfusion during the organ harvesting process
- Participation of the patient in another study or clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Miguel Servet University Hospital
Zaragoza, Zaragoza
Pedro Moreo
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Kidney Transplantation
- Being tested
- Ex vivo normothermic perfusion, Cold preservation
- Keywords
- Kidney, Transplantation, EBERS, EVNP, Ex vivo normothermic perfusion, DCD, DBD, Delayed Graft Function
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo normothermic perfusionDevice
Also called EVNP
Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System
Cold preservationDevice
Also called SCS/HMP
Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Ex vivo normothermic perfusion (EVNP) of the graft with the Ark Kidney System Receives: Device: Ex vivo normothermic perfusion |
| Historical control group | Active comparator | 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. Receives: Device: Cold preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (14)
Delayed graft function (DGF)
Delayed graft function (DGF), defined as the need for dialysis during the first week after transplantation
Measured: 1 week
Duration (in days) of delayed graft function (DGF)
Duration (in days) of delayed graft function (DGF)
Measured: 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.
Measured: 1 week
Primary non-function (PNF)
Primary non-function (PNF)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Patient survival
Patient survival
Measured: 1 year
Graft survival
Graft survival
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start14 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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 and compare it by means of retrospective matching with static cold storage.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebers Medical Technology, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Gutierrez-Dalmau, MD, Principal investigator, Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175885
- Sponsor's protocol ID
- KidneyARK
- Acronym
- KidneyARK
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05175885
- Acronym / sponsor ID
- KidneyARK / KidneyARK
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, Transplantation, EBERS, EVNP, Ex vivo normothermic perfusion, DCD, DBD, Delayed Graft Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ebers Medical Technology, S.L.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 and compare it by means of retrospective matching with static cold storage.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Ex vivo normothermic perfusionEx vivo normothermic perfusion (EVNP) of the graft with the Ark Kidney System |
| Historical control group | Active comparator | Device: Cold preservationNonrandomized historical control group formed by patients transplanted without ex vivo normothermic perfusion (EVNP) in the period Sept 2015-Sept 2020, selected by retrospective matching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- Recipients with body mass index (BMI) > 40 kg/m2
- Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex vivo normothermic perfusionAlso: EVNPEx vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System | Device | Experimental group |
| Cold preservationAlso: SCS/HMPStatic cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft | Device | Historical control group |
Primary outcome
Safety of EVNP in kidney transplantation from DCD and DBD donors as evaluated by assessment of adverse events
Time frame: 1 year
The rate of adverse events will be compared in intervention arm and control arm
14 secondary outcomes
Delayed graft function (DGF)
Time frame: 1 week
Duration (in days) of delayed graft function (DGF)
Time frame: 1 month
Proportion of patients with functional delayed graft function (fDGF)
Time frame: 1 week
Primary non-function (PNF)
Time frame: 1 week
Graft renal function (1 day)
Time frame: 1 day
Graft renal function (3 days)
Time frame: 3 days
Graft renal function (5 days)
Time frame: 5 days
Graft renal function (7 days)
Time frame: 7 days
Graft renal function (30 days)
Time frame: 30 days
Graft renal function (90 days)
Time frame: 90 days
Patient survival
Time frame: 1 year
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
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
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Gutierrez-Dalmau, MD principal investigator
Miguel Servet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ex vivo normothermic perfusion and Cold preservation in people with Kidney Transplantation, run by Ebers Medical Technology, S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Moreo Calvo, PhD (+34 876 013 826, info@ebersmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of EVNP in kidney transplantation from DCD and DBD donors as evaluated by assessment of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.