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
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Device: Kidney perfusion pump||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|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)|
|Official Title:||Feasibility of Subnormothermic Oxygenated Machine Perfusion for Protection of Renal Allografts: A Single Centre Pilot Study|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540640
|Contact: Patrick Luke, MDfirstname.lastname@example.org|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|Contact: Patrick Luke, MD|
|Principal Investigator:||Patrick Luke, MD||Lawson Health Research Institute|