Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

ID#: NCT05653232

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 19, 2023

End Date: March 01, 2027

Contact Information:
Christine Durand, MD
410-955-5684
Summary: This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups: Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks. Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.
Eligibility:

Inclusion Criteria:

- Participant meets the standard criteria for KT at local center.

- Participant is able to understand and provide informed consent.

- Participant is ≥ 18 years old.

Exclusion Criteria:

- Participant has active HCV infection (detectable HCV RNA) at time of screening.

- Participant has a Fibrosis-4 (FIB-4) score ≥ 3.25 at time of screening, or a history of cirrhosis or advanced liver fibrosis.

- Participant's aspartate aminotransferase (AST) or ALT > 2.5 times the upper limit of normal (ULN), within 60 days of screen.

- Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.

- Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.

- Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.

- Participant is pregnant or breastfeeding.
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