Utilization of Hepatitis C Positive Kidneys in Negative Recipients

• Status: Completed
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

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), HCV, and hepatitis B virus (HBV) serology and blood HCV 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%