Status:
COMPLETED
Utilization of Hepatitis C Positive Kidneys in Negative Recipients
Lead Sponsor:
Ohio State University
Conditions:
Kidney Transplant
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Recipient Inclusion/
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03801707
Start Date
March 22 2019
End Date
April 30 2021
Last Update
September 13 2023
Active Locations (1)
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1
Brenda Cuson
Columbus, Ohio, United States, 43210