Live Kidney Donors With Positive Anti-HCV Antibody, But Negative HCV PCR

Completed · Not applicable

Conditions studied: ESRD, Hepatitis C

In brief

It is well recognized that a subset of patients who contracts Hepatitis C virus (HCV) spontaneously clears the virus. Such individuals are anti-HCV antibody positive, yet HCV RNA PCR negative in the blood. While they have not been considered candidates for live kidney donation in the past, with the recent availability of novel anti-HCV drugs with \>95% cure rates, they now represent a potential pool of donor candidates, especially since the risk for transmission of HCV to the recipient is extremely low. The investigators goal is to demonstrate that live kidney donation from anti-HCV positive, HCV RNA PCR negative individuals is safe and carries a negligible risk of viral transmission to the recipient.

Key facts

Study ID

NCT02669966

Run by

University of Florida

People needed

2

Starts

2016-03-01

Expected to finish

2020-02-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Donor inclusion criteria:
• The donor candidate must be anti-HCV positive by ELISA and HCV RNA negative by PCR, with both tests repeated for confirmation, as per standard protocol.
• The donor must be evaluated and cleared by Hepatology, which is currently the standard of care for HCV seropositive individuals.
• The donor must meet criteria for living kidney donation and be approved by the UF Health Shands Kidney Transplant Medical Review Board.
• Recipient inclusion criteria:
• The recipient may be HCV antibody negative or anti-HCV antibody positive but HCV RNA negative by PCR.
• The recipient must meet the criteria for kidney transplantation and be approved by the UF Health Kidney Transplant Program Medical Review Board.

Where it is running

• Shands at the University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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