Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients (NCT05653232)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: University of California San Diego — La Jolla, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- University of California San Diego — La Jolla, California
- Loma Linda University Health — Loma Linda, California
- Johns Hopkins University — Baltimore, Maryland
- NYU Langone Health — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- University of Utah Medical Center — Salt Lake City, Utah
- Virginia Commonwealth University — Richmond, Virginia
- University of Wisconsin, Madison — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.