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

Part of paid clinical trials in La Jolla, California.

Sponsor
Johns Hopkins University
Study ID
NCT05653232
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

Start date
Apr 19, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse [ Time Frame: Within 26 weeks of transplant ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037
Saima Aslam, MD
[email protected]
Saima Aslam, MD (PRINCIPAL_INVESTIGATOR)
Loma Linda University HealthLoma LindaCalifornia92408
Mina Rakoski, MD
[email protected]
Mina Rakoski, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21205
Christine Durand, MD
[email protected]
410-955-5684
Christine Durand, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Susan Lerner, MD
[email protected]
Susan Lerner, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Aprajita Mattoo, MD
[email protected]
Aprajita Mattoo, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Fernanda Silveira, MD
[email protected]
Fernanda Silveira, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Medical CenterSalt Lake CityUtah84132
Miklos Molnar, MD, PhD
[email protected]
Miklos Molnar, MD, PhD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Gaurav Gupta, MD
[email protected]
Gaurav Gupta, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin, MadisonMadisonWisconsin53792-

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University of California San Diego· La Jolla, CALoma Linda University Health· Loma Linda, CAJohns Hopkins University· Baltimore, MDIcahn School of Medicine at Mount Sinai· New York, NYNYU Langone Health· New York, NYUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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