Kidney Transplantation Clinical Trial
— SNOPOOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | September 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eligible versus actual kidney perfusions performed to assess study feasibility | 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 | |
Primary | Rate of kidney discard or graft failure attributed to the study 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 | Rate of delayed graft function in study participants | The need for post-transplant dialysis in study participants will be recorded | 1 year post-transplantation | |
Secondary | Degree of ischemia-reperfusion injury by kidney biopsy | 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 | |
Secondary | Post-transplant serum creatinine levels to assess graft function | 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 | |
Secondary | Rate of primary non-function of kidney grafts in study participants | 1 year post-transplantation |
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