Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2020-03-30

Brief Summary

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Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).

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Detailed Description

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The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.

Conditions

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Reperfusion Injury Hypothermic Oxygenated Machine Perfusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pilot study, case matched (1:2)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional cold storage

Conventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)

Group Type ACTIVE_COMPARATOR

Conventional cold storage

Intervention Type OTHER

No intervention

Hypothermic oxygenated perfusion (HOPE)

HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)

Group Type EXPERIMENTAL

HOPE

Intervention Type PROCEDURE

HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)

Interventions

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HOPE

HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)

Intervention Type PROCEDURE

Conventional cold storage

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.

ECD is defined as followed: deceased donors \> 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension

Exclusion Criteria

1. Recipients of living donor kidney transplants
2. Previous kidney transplantation
3. Participation in other kidney related trials
4. The subject received an investigational drug within 30 days prior to inclusion
5. The subject is unwilling or unable to follow the procedures outlined in the protocol
6. The subject is mentally or legally incapacitated
7. Non-German or non-English speakers
8. Family members of the investigators or employees of the participating department
9. The subject is mentally or legally incapacitated
10. The subject suffers from uncontrolled bacterial or viral infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No