NCT05653232 Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients
| NCT ID | NCT05653232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | HCV |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-04-19 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-04-19 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Christine Durand, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05653232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05653232 currently recruiting?
Yes, NCT05653232 is actively recruiting participants. Contact the research team at cdurand2@jhmi.edu for enrollment information.
Where is the NCT05653232 trial being conducted?
This trial is being conducted at La Jolla, United States, Loma Linda, United States, Baltimore, United States, New York, United States and 5 additional locations.
Who is sponsoring the NCT05653232 clinical trial?
NCT05653232 is sponsored by Johns Hopkins University. The principal investigator is Christine Durand, MD at Johns Hopkins University. The trial plans to enroll 120 participants.