Ex Vivo Normothermic Perfusion in Kidney Transplantation.

NCT05175885 | Recruiting DMC

• 1 other identifier: KidneyARK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Kidney; Transplantation; EBERS; EVNP; Ex vivo normothermic perfusion; DCD; DBD; Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (14)

• Delayed graft function (DGF)

  1 week

• Duration (in days) of delayed graft function (DGF)

  1 month

• Proportion of patients with functional delayed graft function (fDGF)

  1 week

• Primary non-function (PNF)

  1 week

• Graft renal function (1 day)

  1 day

Study Arms (2)

Experimental group

EXPERIMENTAL

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

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.

Device: Cold preservation

Interventions

Ex vivo normothermic perfusion DEVICE

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

Also known as: EVNP

Experimental group

Cold preservation DEVICE

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

Also known as: SCS/HMP

Historical control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Ebers Medical Technology, S.L.: lead

Study Sites (1)

Miguel Servet University Hospital

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Cryopreservation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Alex Gutierrez-Dalmau, MD

  Miguel Servet University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Moreo Calvo, PhD

CONTACT

+34 876 013 826; info@ebersmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 4, 2022
• Study Start: December 14, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)