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

Recruiting

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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 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.

About the study

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.

What is being tested

Prophylaxis (P2W) (other)
Transmit and Treat (T&T) (other)

Sponsor: Johns Hopkins University · Participants: 120 · Started: Apr 19, 2023

Contact the study team

Christine Durand, MD · Phone: 410-955-5684

Official record on ClinicalTrials.gov — NCT05653232

Locations in the U.S.

California	University of California San Diego, La Jolla Loma Linda University Health, Loma Linda
Maryland	Johns Hopkins University, Baltimore
New York	Icahn School of Medicine at Mount Sinai, New York NYU Langone Health, New York
Pennsylvania	University of Pittsburgh Medical Center, Pittsburgh
Virginia	Virginia Commonwealth University, Richmond

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.