Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant meets the standard criteria for KT at local center.
• Participant is able to understand and provide informed consent.
• Participant is ≥ 18 years old.
Locations
United States
California
University of California San Diego
RECRUITING
La Jolla
Maryland
Johns Hopkins University
RECRUITING
Baltimore
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Utah
University of Utah Medical Center
RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Wisconsin
University of Wisconsin, Madison
RECRUITING
Madison
Contact Information
Primary
Christine Durand, MD
cdurand2@jhmi.edu
410-955-5684
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2027-03
Participants
Target number of participants: 120
Treatments
Experimental: Prophylaxis (P2W)
Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks.
Experimental: Transmit and Treat (T&T)
T\&T is study-supplied SOF/VEL for 12 weeks starting on post-HCV D+/R- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Johns Hopkins University