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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System
Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft
Miguel Servet University Hospital
Zaragoza, Spain
RECRUITINGSafety 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.
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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