Utilization of Hepatitis C Positive Kidneys in Negative Recipients

An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

Recipient Inclusion/Exclusion Criteria:

Inclusion Criteria:

• Adult age >18 years able to provide consent
• Lack of available living donor
• Calculated pre-transplant reactive panel (cPRA) of <80%
• Estimated post-transplant survival (EPTS) index >20% and <80%
• Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
• No clinically significant pre-transplant liver disease

Exclusion Criteria:

• Living donor available
• Dialysis time >5 years
• Listing for multi-organ transplantation
• Active or recent history (<6 months) of alcohol abuse or substance abuse
• Clinically significant liver disease as determined by principal investigator
• History of hepatocarcinoma
• Pregnancy or lactation
• Refusal to accept blood transfusion
• HIV infection
• HCV pcr or antibody positive
• HBV infection

Donor Inclusion Criteria:

• Positive HCV PCR at time of donation
• Kidney donor profile index (KDPI)<85%