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

NCT05653232 | Recruiting DMC

• 2 other identifiers: IRB00316833U01AI157931
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

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.

Conditions

HCV

Outcome Measures

Primary Outcomes (2)

• Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse

  Proportion of events in each arm.

  Within 26 weeks of transplant

• Number of participants with liver injury

  Measured with a longitudinal model of Alanine aminotransferase (ALT).

  The first 28 days post-transplant

Secondary Outcomes (11)

• Participant survival

  At 6 months and 1 year post-transplant

• Graft survival

  At 6 months and 1 year post-transplant

• HCV plasma RNA

  At week 26 post-transplant

• Graft rejection

  At 6 months and 1 year post-transplant

• Prevalence of donor specific antibody (DSA)

  At 4 weeks and 6 months post-transplant, and with any episode of clinically suspected or proven rejection.

Study Arms (2)

Prophylaxis (P2W)

EXPERIMENTAL

Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks.

Other: Prophylaxis (P2W)

Transmit and Treat (T&T)

EXPERIMENTAL

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.

Other: Transmit and Treat (T&T)

Interventions

Prophylaxis (P2W) OTHER

For participants enrolled in P2W arm, the initial dose of SOF/VEL will be administered to the recipient when called to the operating room for transplant (typically 1-3 hours prior to the start of surgery). Post-transplant, SOF/VEL will be continued daily for 13 days post-KT (a total of 14 doses administered).

Prophylaxis (P2W)

Transmit and Treat (T&T) OTHER

For participants enrolled in T\&T arm, SOF/VEL will begin between post-KT day 0 and post-KT day 14. Participants will be clinically-prescribed DAAs once viremia is detected, and participant's insurance will be petitioned to obtain treatment as soon as possible. If insurance-provided DAAs are approved before post-KT day 14, participant will begin 12 weeks of study-provided SOF/VEL on date of insurance-provided DAAs approval. If insurance-provided DAAs are not approved by post-KT day 14, study-provided SOF/VEL will begin on post-KT day 14 and continue for 12 weeks.

Transmit and Treat (T&T)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant meets the standard criteria for KT at local center.
• Participant is able to understand and provide informed consent.
• Participant is ≥ 18 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (9)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Loma Linda University Health

Loma Linda, California, 92408, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

TERMINATED

MeSH Terms

Interventions

Disease Transmission, Infectious; Coal Tar

Intervention Hierarchy (Ancestors)

Public Health; Environment and Public Health; Tars; Complex Mixtures

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Durand, MD

CONTACT

410-955-5684; cdurand2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 16, 2022
• Study Start: April 19, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)