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

NCT02669966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-02-19

No results posted yet for this study

Summary

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.

Conditions

  • ESRD
  • Hepatitis C

Interventions

PROCEDURE

Kidney transplantation

Once the donor and recipient candidates have met inclusion criteria and cleared study-specific as well as standard of care screening, they will proceed to live-donor kidney transplantation and subsequent post-transplant monitoring

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Karl Womer, MD · Univesity of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669966 on ClinicalTrials.gov