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

Recruiting now · Not applicable

Conditions studied: HCV

In brief

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.

Key facts

Study ID

NCT05653232

Run by

Johns Hopkins University

People needed

120

Starts

2023-04-19

Expected to finish

2027-03-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant meets the standard criteria for KT at local center.
• Participant is able to understand and provide informed consent.
• Participant is ≥ 18 years old.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.