Multi-center Study to Transplant Hepatitis-C Infected Kidneys

The study objective is to determine if the administration of the direct acting antiviral
glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective
at preventing the spread of HCV infection from donor kidney with known HCV infection (all
genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks
post treatment.

Inclusion Criteria:

- Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2

- Blood group O, A, or B

- Listed for an isolated kidney transplantation

- Waiting list priority time

1. For blood group O or B patients: <912 days of accrued waiting list priority time

2. For blood group A patients: <730 days of accrued waiting list priority time

- Able to understand and adhere to the study visit schedule and all other protocol
requirements, and must voluntarily sign and date an informed consent

- No available medically acceptable, compatible living kidney donor

- Subject must agree to use an effective method of birth control per protocol
specifications

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to
immunosuppressants utilized in kidney transplant

- Female who is pregnant, breastfeeding, or is planning to become pregnant during the
course of the study

- History of HIV

- HCV RNA positive

- HBV surface Ag-positive or detectable HBV DNA

- Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased
risk of causing early graft failure as assessed by the transplant nephrologist and/or
investigator team

- Presence of clinically significant liver disease

- Transplant candidate requiring antibody desensitization protocol for transplantation

- Most recent calculated panel reactive antibody (cPRA) >80%.

- Prior recipient of a non-renal solid organ transplant