Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation

Donor Inclusion Criteria:

1. Donor kidney suitable for preservation
2. Only one kidney per donor will be included
3. Cold ischemia time (CIT) ≤ 24 hours
4. Donor age over 18 years old

5. Donor meets one of the following:

   1. Donor after brain death (DBD), standard and extended criteria
   2. Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
6. Signed written informed consent

Donor Exclusion Criteria:

1. Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon
2. Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
3. Living donors
4. Previous usage of a perfusion machine (PM)
5. Kidneys not considered suitable for preservations
6. Positive serology (HIV, Hepatitis B surface antigen \& C)

Recipient Inclusion Criteria:

1. Registered primary kidney transplant candidate, male or female
2. Age ≥ 18 years old
3. Signed written informed consent

Recipient Exclusion Criteria:

1. Prior solid organ or bone marrow transplant
2. Multi-organ transplant
3. Active malignancy
4. Active infection
5. Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
6. Participation in another clinical trial.
7. Patient with known donor-specific HLA antibody