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Comparing Hepatitis C Prevention Strategies for Kidney Transplant Recipients

This study is investigating the best way to prevent Hepatitis C Virus (HCV) infection in people receiving a kidney transplant from a donor who has HCV. You would be randomly assigned to one of two groups. One group will receive sofosbuvir/velpatasvir (SOF/VEL), a medication that treats HCV, before the transplant and for two weeks afterward. The other group will receive SOF/VEL after the transplant if HCV is detected, and will take it for 12 weeks. The study aims to see if starting treatment earlier prevents HCV-related problems or liver injury. We are looking for 120 participants who are at least 18 years old, need a kidney transplant, and do not currently have an active HCV infection or advanced liver scarring.

Study design
This is an interventional study that will randomly assign 120 participants to one of two treatment groups.
What's involved
Participants in the prophylaxis group will take SOF/VEL for 14 days, starting 1-3 hours before transplant. Participants in the transmit and treat group will take SOF/VEL for 12 weeks, starting between day 0 and day 14 post-transplant if HCV is detected.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to HCV and liver injury within 26 weeks of transplant and during the first 28 days post-transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05653232

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

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~120 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Prophylaxis (P2W)Transmit and Treat (T&T)

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse
Measured over Within 26 weeks of transplant
+1 more outcome measured

Conditions

HCV

Explore related trials

Kidney Transplantation

Where it's being run

9 sites across 7 states
California2
New York2
Maryland1
Pennsylvania1
Utah1
Virginia1
Wisconsin1

Study leadership

  • Christine Durand, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Christine Durand, MD
[email protected]
410-955-5684
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapseWithin 26 weeks of transplant

    Proportion of events in each arm.

  • Number of participants with liver injuryThe first 28 days post-transplant

    Measured with a longitudinal model of Alanine aminotransferase (ALT).