Clinical trial NCT05175885: Ex Vivo Normothermic Perfusion in Kidney Transplantation.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Keywords: Kidney
Transplantation
EBERS
EVNP
Ex vivo normothermic perfusion
DCD
DBD
Delayed Graft Function
Lead sponsor: Ebers Medical Technology, S.L.
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective site.
3. 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.
4. 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.
5. Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study.
6. Patients that meet the acceptance criteria for kidney transplant recipients established in the clinical site in agreement with usual clinical practice.

Exclusion Criteria:

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

   1. Expected cold ischemia time before EVNP \> 20 hours
   2. Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor
   3. Organ with multiple arteries
4. Recipients with body mass index (BMI) \> 40 kg/m2
5. Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator.
6. Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at the moment of inclusion
7. Diagnosis of antiphospholipid syndrome at the moment of inclusion
8. Panel-reactive antibodies (PRA) score \> 50%
9. Known allergies to any of the components of the perfusate
10. Preexisting vascular disease that represents an extraordinary technical difficulty for the transplantation in the opinion of the investigator
11. Presence of clinically relevant donor-specific anti-HLA antibodies
12. ABO incompatibility
13. History of alcohol or drug abuse in the last two years
14. Use of normothermic regional perfusion during the organ harvesting process
15. Participation of the patient in another study or clinical trial.

Primary outcomes:
measure: Safety of EVNP in kidney transplantation from DCD and DBD donors as evaluated by assessment of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Delayed graft function (DGF)
timeFrame: 1 week
measure: Duration (in days) of delayed graft function (DGF)
timeFrame: 1 month
measure: Proportion of patients with functional delayed graft function (fDGF)
timeFrame: 1 week
measure: Primary non-function (PNF)
timeFrame: 1 week
measure: Graft renal function (1 day)
timeFrame: 1 day
measure: Graft renal function (3 days)
timeFrame: 3 days
measure: Graft renal function (5 days)
timeFrame: 5 days
measure: Graft renal function (7 days)
timeFrame: 7 days
measure: Graft renal function (30 days)
timeFrame: 30 days
measure: Graft renal function (90 days)
timeFrame: 90 days
measure: Patient survival
timeFrame: 1 year
measure: Graft survival
timeFrame: 1 year
measure: 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
timeFrame: 1 day
measure: Viability of EVNP in kidney transplantation from DCD and DBD donors as evaluated by the ratio of planned vs. perfused organs
timeFrame: 1 day
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet University Hospital
name: Alex Gutierrez-Dalmau, MD
role: PRINCIPAL_INVESTIGATOR
References: