Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Completed · Phase 2/Phase 3

Conditions studied: Kidney Transplant, Hepatitis C, HCV

In brief

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

Key facts

Study ID

NCT03801707

Run by

Ohio State University

People needed

54

Starts

2019-03-22

Expected to finish

2021-04-30

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Brenda Cuson — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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