A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

Prior treatment

• Transplant candidate requires antibody desensitization protocol for transplantation
• Participation in another interventional study, from a period starting 6 months prior to screening to last study visit, that the study PIs judge would interfere with either the aims or the safety of the THINKER-NEXT study.

Other illness

• Hepatitis B surface antigen and/or DNA positive
• Active Hepatitis C infection
• HIV RNA-positive or HIV antibody positive
• Other chronic liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\] with normal liver enzymes)
• Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist

Lab values

• Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)

Other

• Hepatocellular carcinoma
• Advanced hepatic fibrosis or cirrhosis
• Current use of amiodarone or dronedarone (due to interaction with sofosbuvir)
• Female who is pregnant, planning to become pregnant during the study, or breast-feeding

• Able to provide informed consent
• Active waiting list status for isolated kidney transplant
• 18 years of age or older
• No living kidney donor
• Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be included unless patient has a most recent cytotoxic PRA of \>25% or calculated PRA \>50% where multiple moderate level HLA antibodies exist and in the opinion of the local site investigator represents substantial HLA sensitization. If patient has a PRA of 98-100%, the donor-recipient pair must meet additional eligibility criteria.