What this study is
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.
What's being tested
- Prophylaxis (P2W)
Intervention · 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)
Intervention · 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
- Official title
- Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial
- Sponsor
- Johns Hopkins University
- Conditions
- HCV
- Enrolling
- 120 people
- Starts
- 2023-04-19
- Est. completion
- 2028-03
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
7 openUniversity of California San Diego
La Jolla, California, United States
- Saima Aslam, MD · Contactsaslam@ucsd.edu
- Saima Aslam, MD · Principal investigator
RecruitingLoma Linda University Health
Loma Linda, California, United States
- Mina Rakoski, MD · Contactmrakoski@llu.edu
- Mina Rakoski, MD · Principal investigator
RecruitingJohns Hopkins University
Baltimore, Maryland, United States
- Christine Durand, MD · Contact410-955-5684cdurand2@jhmi.edu
- Christine Durand, MD · Principal investigator
RecruitingNYU Langone Health
New York, New York, United States
- Aprajita Mattoo, MD · ContactAprajita.Matoo@nyulangone.org
- Aprajita Mattoo, MD · Principal investigator
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Susan Lerner, MD · ContactSusan.Lerner@mountsinai.org
- Susan Lerner, MD · Principal investigator
RecruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
- Fernanda Silveira, MD · Contactsilvfd@upmc.edu
- Fernanda Silveira, MD · Principal investigator
RecruitingVirginia Commonwealth University
Richmond, Virginia, United States
- Gaurav Gupta, MD · Contactgaurav.gupta@vcuhealth.org
- Gaurav Gupta, MD · Principal investigator
RecruitingUniversity of Utah Medical Center
Salt Lake City, Utah, United States
Active, not recruitingUniversity of Wisconsin, Madison
Madison, Wisconsin, United States
Terminated
Study team
Sponsor
Johns Hopkins University
Study ID IRB00316833
Principal investigator
Christine Durand, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.