- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540640
Oxygenated Machine Preservation in Kidney Transplantation (SNOPO)
Feasibility of Subnormothermic Oxygenated Machine Perfusion for Protection of Renal Allografts: A Single Centre Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
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.
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The pulsatile perfusion device will circulate room temperature oxygenated perfusion solution through the donor kidney ex vivo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligible versus actual kidney perfusions performed to assess study feasibility
Time Frame: 1 year from start of study
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Ratio of kidneys grafts that are planned to receive the study intervention compared to the actual number of grafts perfused by study device.
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1 year from start of study
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Rate of kidney discard or graft failure attributed to the study intervention
Time Frame: From first study intervention to 1 year after last intervention
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Complications related to ex vivo perfusion that result in graft discard prior to transplantation or graft failure post-transplantation will be recorded.
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From first study intervention to 1 year after last intervention
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Secondary Outcome Measures
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
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1 year post-transplantation
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Degree of ischemia-reperfusion injury by kidney biopsy
Time Frame: 3 months after enrolment of last participant
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Pre and post-implantation kidney biopsies will be graded as per standard histological criteria to assess for ischemia-reperfusion injury
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3 months after enrolment of last participant
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Post-transplant serum creatinine levels to assess graft function
Time Frame: From first study intervention to 1 year after transplantation of final participant
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Serum creatinine levels will be interpreted as per clinical standard, with higher levels indicating poorer graft function
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From first study intervention to 1 year after transplantation of final participant
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Rate of primary non-function of kidney grafts in study participants
Time Frame: 1 year post-transplantation
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1 year post-transplantation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Luke, MD, Lawson Health Research Institute
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 116275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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