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A Single Centre Study of the Feasibility and Safety of Using Normothermic ex Vivo Machine Perfusion to Store Human Kidneys for Transplantation. (NEVKP)
Kidney transplantation is the treatment of choice for end-stage kidney failure, but access to transplantation is limited by a severe shortage of donor organs. Although the use of kidneys from higher risk deceased donors has increased the availability of organs, these grafts are associated with a greater risk of delayed function, inferior performance, and shorter survival than standard criteria donor kidneys. The current standard of care for kidney graft preservation prior to transplantation is static cold storage. Preliminary results from large animal kidney transplantation studies and a human clinical trial suggest that normothermic machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by kidney grafts during cold static preservation, allow assessment of organ viability prior to transplantation, and reduce the risk of delayed graft function or non-function. Such a strategy may not only improve the performance of kidneys that are currently considered acceptable for transplantation, but may also facilitate the assessment and utilization of kidneys that are currently not considered for transplantation. This study will examine the feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to transplantation. The study will evaluate kidney function after transplantation using standard clinical parameters. Study participants will be followed for 3 months following transplantation and their outcomes recorded. Feasibility will be measured using the ratio of actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take into account logistical issues with respect to implementation and ease of use of the ex vivo perfusion device. Safety will be assessed by rates of device failure resulting in organ discard, primary graft non-function, delayed graft function, graft failure, and recipient mortality.
Details
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 13 |
| Start date | 2016-12-19 |
| Completion | 2020-06 |
Conditions
- Kidney Transplantation
Interventions
- Normothermic ex-vivo kidney perfusion Solution -Toronto
Primary outcomes
- the ratio of actual / eligible kidney grafts subjected to study intervention. — assessed 3 months after enrollment of final participant, or up to 48 months, whichever is earlier
planned versus actual kidney perfusions to assess study feasibility - The rate of kidney discard or graft failure attributable to the study intervention — from date of first actual intervention to date last participant completes the study followup period of 3 months post-intervention
organ discard or graft failure directly attributable to the use of normothermic perfusion
Countries
Canada