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Oxygenated Machine Preservation in Kidney Transplantation (SNOPO)

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ClinicalTrials.gov Identifier: NCT04540640
Recruitment Status : Not yet recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Luke, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE August 25, 2020
First Posted Date  ICMJE September 7, 2020
Last Update Posted Date September 7, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • 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
  • 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
  • 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
  • Rate of primary non-function of kidney grafts in study participants [ Time Frame: 1 year post-transplantation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxygenated Machine Preservation in Kidney Transplantation
Official Title  ICMJE Feasibility of Subnormothermic Oxygenated Machine Perfusion for Protection of Renal Allografts: A Single Centre Pilot Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
A pilot study assessing the feasibility of procedures and preliminary safety of study device and perfusion solution.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE Device: Kidney perfusion pump
The pulsatile perfusion device will circulate room temperature oxygenated perfusion solution through the donor kidney ex vivo.
Study Arms  ICMJE 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.
Intervention: Device: Kidney perfusion pump
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patrick Luke, MD 519-663-3180 patrick.luke@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04540640
Other Study ID Numbers  ICMJE 116275
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Patrick Luke, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Luke, MD Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP