Actively Recruiting
Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
Led by Johns Hopkins University · Updated on 2026-02-17
120
Participants Needed
9
Research Sites
25 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the best time to start medication for Hepatitis C Virus (HCV) in kidney transplant recipients who are HCV-negative but receive kidneys from HCV-positive donors. This study compares two approaches to giving the medication sofosbuvir/velpatasvir (SOF/VEL), a combination of direct-acting antiviral agents (DAAs) that block HCV from multiplying. The aim is to understand if starting treatment before transplant with a short course or after transplant with a full course better prevents HCV infection in these recipients. Participants will be randomly assigned to one of two groups. The first group (Prophylaxis) will take SOF/VEL starting before the transplant and continue for 2 weeks total. The second group (Transmit and Treat) will begin SOF/VEL after the transplant, starting no later than 14 days post-surgery, and continue for 12 weeks. The study drug is approved for 12 weeks of treatment, but its use in a shorter 2-week prophylactic course is being studied here. During the study, participant health will be closely monitored with assessments including liver injury within 28 days post-transplant and composite events related to HCV or treatment within 26 weeks. Additional evaluations will track survival, graft function, rejection, infections, and resistance to the virus up to one year or longer after transplant. This comprehensive monitoring aims to evaluate the safety and outcomes of both medication timing strategies over several months to years following transplant.
CONDITIONS
Brief Title
Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant meets the standard criteria for kidney transplant at local center
- Participant is able to understand and provide informed consent
- Participant is 18 years of age or older
You will not qualify if you...
- Participant has active Hepatitis C Virus infection (detectable HCV RNA) at time of screening
- Participant has cirrhosis or advanced liver fibrosis
- Participant's aspartate aminotransferase (AST) or ALT is more than 2.5 times the upper limit of normal within 60 days of screening
- Participant has human immunodeficiency virus infection (HIV) or active hepatitis B infection
- Participant is unable to safely substitute or discontinue a medication that conflicts with the study medication
- Past or current medical problems that may pose additional risks, interfere with study compliance, or affect data quality
- Participant is pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks or 12 weeks depending on treatment arm
Participants receive sofosbuvir/velpatasvir (SOF/VEL) as either prophylaxis starting before transplant and continuing for 2 weeks post-transplant, or as transmit-and-treat starting no later than 14 days post-transplant and continuing for 12 weeks.
1 pre-transplant dose and daily dosing post-transplant for up to 12 weeks
Duration - Up to 3 years post-transplant
Participants are monitored for HCV-related events, liver injury, graft function, and infections for up to 1 year post-transplant, with ongoing assessments for complications and survival up to 3 years.
Visits at multiple timepoints including weeks 4, 26, and months 3, 6, 9, 12, and annually thereafter
Trial Site Locations
Total: 9 locations
1
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
Loma Linda University Health
Loma Linda, California, United States, 92408
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
8
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
9
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53792
Terminated
Research Team
C
Christine Durand, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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