Status:
COMPLETED
Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Kidney Transplant
Hepatitis C
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus (HCV) has changed the landscape of HCV therapy dramatically in the last several years with reported sustained...
Detailed Description
Traditionally, HCV+ kidneys are not offered to HCV- patients on the waiting list. The primary concern with offering HCV+ kidneys to HCV- recipients is a risk of viral transmission. Although data about...
Eligibility Criteria
Inclusion
- No evidence of HCV infection by HCV PCR (done at the time of the initial consent)
- Age\>60 yrs with an expected waiting time\>2 years; or
- Age\<60 yrs with any one of the following risk factors: Diabetes, coronary artery disease, peripheral artery disease and/or cerebrovascular disease
- Willingness to provide informed consent
- Absence of a living donor.
Exclusion
- Estimated life expectancy of less than one year based on clinical judgment of the investigator
- Prior liver or renal transplantation
- Pregnant women
- Incarcerated patients
- Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
- Unable or unwilling to return for follow-up visits
- Donor
Key Trial Info
Start Date :
August 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03249194
Start Date
August 17 2017
End Date
March 15 2020
Last Update
March 27 2020
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298