Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05653232

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

Led by Johns Hopkins University · Updated on 2026-02-17

120

Participants Needed

9

Research Sites

201 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant meets the standard criteria for kidney transplant at the local center
  • Participant can understand and provide informed consent
  • Participant is 18 years old or older
Not Eligible

You will not qualify if you...

  • Participant has active Hepatitis C Virus infection (detectable HCV RNA) at screening
  • Participant has cirrhosis or advanced liver fibrosis
  • Participant's liver enzymes (AST or ALT) are more than 2.5 times the normal limit within 60 days of screening
  • Participant has human immunodeficiency virus (HIV) or active hepatitis B infection
  • Participant cannot safely stop or replace a medication that conflicts with the study drug
  • Participant has medical conditions that increase risk, interfere with study participation, or affect data quality
  • Participant is pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Christine Durand, MD

CONTACT

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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