Ex Vivo Normothermic Perfusion in Kidney Transplantation.

NCT ID: NCT05175885

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-14
• Study Completion Date: 2027-12-31

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Ex vivo normothermic perfusion (EVNP) of the graft with the Ark Kidney System

Group Type: EXPERIMENTAL

Ex vivo normothermic perfusion

Intervention Type: DEVICE

Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System

Historical control group

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.

Group Type: ACTIVE_COMPARATOR

Cold preservation

Intervention Type: DEVICE

Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft

Interventions

Ex vivo normothermic perfusion

Ex vivo normothermic perfusion (EVNP) of the renal graft with the Ark Kidney System

Intervention Type: DEVICE

Cold preservation

Static cold storage (SCS) or hypothermic machine perfusion (HMP) of the renal graft

Intervention Type: DEVICE

Other Intervention Names

EVNP; SCS/HMP

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ebers Medical Technology, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Gutierrez-Dalmau, MD

Role: PRINCIPAL_INVESTIGATOR

Miguel Servet University Hospital

Locations

Miguel Servet University Hospital

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pedro Moreo Calvo, PhD

Role: CONTACT

info@ebersmedical.com

+34 876 013 826

Facility Contacts

Pedro Moreo

Role: primary

Other Identifiers

KidneyARK

Identifier Type: -

Identifier Source: org_study_id