Oxygenated Machine Preservation in Kidney Transplantation

NCT04540640 | Unknown FDA Device

• 1 other identifier: 116275
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Perfusion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Rate of delayed graft function in study participants

  1 year post-transplantation

• Degree of ischemia-reperfusion injury by kidney biopsy

  3 months after enrolment of last participant

• Post-transplant serum creatinine levels to assess graft function

  From first study intervention to 1 year after transplantation of final participant

• Rate of primary non-function of kidney grafts in study participants

  1 year post-transplantation

Study Arms (1)

Subnormothermic Perfusion

EXPERIMENTAL

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

Interventions

Kidney perfusion pump DEVICE

The pulsatile perfusion device will circulate room temperature oxygenated perfusion solution through the donor kidney ex vivo.

Subnormothermic Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or females, 18 years or older
• Active on the kidney transplant waiting list

You may not qualify if:

• Patients receiving a multi-organ transplant (e.g. double kidney, kidney-pancreas)
• Patients who are unable/refuse to provide informed consent
• Single kidney from donation after circulatory death (DCD) or donation after brain death (DBD) donor.
• Kidneys from living donors
• Kidneys that would be declined for transplantation under current clinical practice
• Vascular issues precluding placement on a pump

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Study Officials

• Patrick Luke, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Luke, MD

CONTACT

519-663-3180; patrick.luke@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director of Multi-Organ Transplant

Model Details: A pilot study assessing the feasibility of procedures and preliminary safety of study device and perfusion solution.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 7, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)