RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT05653232

Registry updated: 2026-09-04

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Description

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.

Interventions

Prophylaxis (P2W) (Other)
For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).
Transmit and Treat (T&T) (Other)
For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.

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.

Conditions

HCV

Locations

University of California San Diego — La Jolla, California, United States
Loma Linda University Health — Loma Linda, California, United States
Johns Hopkins University — Baltimore, Maryland, United States
NYU Langone Health — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
University of Utah Medical Center — Salt Lake City, Utah, United States
Virginia Commonwealth University — Richmond, Virginia, United States
University of Wisconsin, Madison — Madison, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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