Oxygenated Machine Preservation in Kidney Transplantation (SNOPO)

September 1, 2020 updated by: Patrick Luke, Lawson Health Research Institute

Feasibility of Subnormothermic Oxygenated Machine Perfusion for Protection of Renal Allografts: A Single Centre Pilot Study

Kidney transplantation remains the best treatment option for patients with end-stage kidney failure, however, the need for transplantable organs far exceeds the number of acceptable grafts available from deceased donors. In an effort to increase access to transplantation, organs from higher risk donors are being used more frequently. Patients who receive these high risk kidneys are more likely to experience poor outcomes post-transplantation, such as delayed graft function and shorter graft survival than those who receive standard criteria donor kidneys. One way to improve outcomes in these high risk kidneys is to limit the amount of damage donor organs sustain during the transplant process. The current standard of care is storage of the donor organ on ice until the time of transplant, during which the kidney incurs injury from cold and lack of oxygen. Recent research suggests that oxygenated machine perfusion of the organ at room temperature as a storage method can help protect kidneys and improve post-transplant outcomes. This study aims to assess the feasibility and safety of room temperature oxygenated machine perfusion of donor kidneys prior to transplantation. Kidney function will be evaluated with standard clinical parameters and participants will be followed for one-year post-transplantation for their outcomes. Feasibility will be evaluated in terms of trial process such as recruitment rate and ease of implementation of the study intervention. Preliminary safety will be assessed by incidence of graft discard and technical limitations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Kidney transplantation remains the treatment of choice for patients suffering from end-stage renal disease. To combat the ever-increasing waiting list, higher risk organs, including those from donation after circulatory death (DCD) donors, and older donors are being transplanted more frequently. However, organs from these donors are more susceptible to damage during the transplant procedure known as ischemia-reperfusion injury (IRI) and show worse outcomes post-transplant such as increased rates of primary non-function, delayed graft function and early graft loss. Therefore, strategies to mitigate IRI are of great interest to improve transplant outcomes. One method of interest is modification of organ storage techniques during the transplant process.

The current standard of care for organ preservation is static cold storage or hypoxic hypothermic pulsatile perfusion of the donor organ. Our pre-clinical studies in a porcine DCD transplant model indicate that perfusion at room temperature is capable of significantly reducing kidney inflammation and damage during the transplant process compared to cold storage and normothermic perfusion. While other trials have looked at hypothermic and normothermic perfusion, to the best of our knowledge there has not been a trial to evaluate subnormothermic perfusion of kidneys.

The study intervention will consist of ex vivo perfusion of donor kidneys using a clinical pulsatile pump modified with an oxygen delivery unit developed by our laboratory. Once organs arrive at the transplant centre they will be attached to the pump by the transplant surgery team and/or perfusionist. Prior to placement on pump, a baseline tissue sample of the kidney will be taken via needle core biopsy. Kidneys will be perfused with a preservation solution composed of a bloodless oxygen carrier. Organs will be perfused for 1-10 hours depending on the clinical timeline of the transplant. The kidney will be transplanted into the recipient as per clinical standard. After reperfusion of the kidney in the recipient, another study tissue sample will be collected via needle core biopsy. Pre-implantation and post-perfusion baseline biopsies are performed as clinical standards, but a small sample of the biopsy specimen will be stored for analysis in our laboratory. Study participants (n=15) will be followed for 1 year post-transplant and their graft function will be assessed using standard clinical parameters.

The goal of this study is to determine the feasibility and preliminary safety of subnormothermic perfusion. Feasibility will be assessed by ease of implementation of study procedures and recruitment rate. Safety will be determined from rate of graft discard attributed to study intervention, graft function and technical limitations of the study intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Participant):

  • Adult male or females, 18 years or older
  • Active on the kidney transplant waiting list

Exclusion Criteria (Participant):

  • Patients receiving a multi-organ transplant (e.g. double kidney, kidney-pancreas)
  • Patients who are unable/refuse to provide informed consent

Inclusion Criteria (Organ):

  • Single kidney from donation after circulatory death (DCD) or donation after brain death (DBD) donor.

Exclusion Criteria (Organ):

  • Kidneys from living donors
  • Kidneys that would be declined for transplantation under current clinical practice
  • Vascular issues precluding placement on a pump

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Subnormothermic Perfusion
Kidneys retrieved for transplantation will undergo subnormothermic oxygenated perfusion using the study device and perfusion solution for at least 1 hour prior to transplantation into the recipient.
Device: Kidney perfusion pump
The pulsatile perfusion device will circulate room temperature oxygenated perfusion solution through the donor kidney ex vivo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eligible versus actual kidney perfusions performed to assess study feasibility
Time Frame: 1 year from start of study
Ratio of kidneys grafts that are planned to receive the study intervention compared to the actual number of grafts perfused by study device.
1 year from start of study
Rate of kidney discard or graft failure attributed to the study intervention
Time Frame: From first study intervention to 1 year after last intervention
Complications related to ex vivo perfusion that result in graft discard prior to transplantation or graft failure post-transplantation will be recorded.
From first study intervention to 1 year after last intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of delayed graft function in study participants
Time Frame: 1 year post-transplantation
The need for post-transplant dialysis in study participants will be recorded
1 year post-transplantation
Degree of ischemia-reperfusion injury by kidney biopsy
Time Frame: 3 months after enrolment of last participant
Pre and post-implantation kidney biopsies will be graded as per standard histological criteria to assess for ischemia-reperfusion injury
3 months after enrolment of last participant
Post-transplant serum creatinine levels to assess graft function
Time Frame: From first study intervention to 1 year after transplantation of final participant
Serum creatinine levels will be interpreted as per clinical standard, with higher levels indicating poorer graft function
From first study intervention to 1 year after transplantation of final participant
Rate of primary non-function of kidney grafts in study participants
Time Frame: 1 year post-transplantation
1 year post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Luke, MD, Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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