RECRUITING

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

Description

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

HCV
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Related Conditions:

HCV

Study Overview

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Study Details

Study overview

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.

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial

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

Condition
HCV
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92037

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21205

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Salt Lake City

University of Utah Medical Center, Salt Lake City, Utah, United States, 84132

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Madison

University of Wisconsin, Madison, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Participant has active HCV infection (detectable HCV RNA) at time of screening.
  • * Participant has a Fibrosis-4 (FIB-4) score ≥ 3.25 at time of screening, or a history of 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Christine Durand, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2027-03