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
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