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

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, La Jolla, Loma Linda, Madison, New York, Pittsburgh, Richmond, and Salt Lake City, United StatesSee the 9 sites
Trial code
Status
Recruiting
People taking part
120 people, planned
Started
19 Apr 2023
Expected to end
Mar 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Prophylaxis (P2W)
  • Transmit and Treat (T&T)
Record updated
4 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

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

Who cannot take part

  • Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication
  • Participant has active HCV infection (detectable HCV RNA) at time of screening
  • Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection
  • Participant's aspartate aminotransferase (AST) or ALT > 2.5 times the upper limit of normal (ULN), within 60 days of screen
  • Participant has cirrhosis or advanced liver fibrosis
  • 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

Where in United States

  • Johns Hopkins UniversityBaltimore, United StatesContact: Christine Durand, MDTaking people
  • University of California San DiegoLa Jolla, United StatesContact: Saima Aslam, MDTaking people
  • Loma Linda University HealthLoma Linda, United StatesContact: Mina Rakoski, MDTaking people
  • University of Wisconsin - MadisonMadison, United StatesContact: Christine Durand, MDNo longer taking part
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Susan Lerner, MDTaking people
  • NYU Langone HealthNew York, United StatesContact: Aprajita Mattoo, MDTaking people
  • University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Fernanda Silveira, MDTaking people
  • Virginia Commonwealth UniversityRichmond, United StatesContact: Gaurav Gupta, MDTaking people
  • University of Utah Medical CenterSalt Lake City, United StatesContact: Christine Durand, MDNo longer taking part

About the trial

What the trial wants to find out

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:

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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.

The 2 groups in the trial

  • Prophylaxis (P2W)Treatment being tested

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

  • Transmit and Treat (T&T)Treatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
Record updated
4 September 2026