Preventing Hepatitis C in Kidney Transplant Recipients from Infected Donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the optimal timing for starting Hepatitis C Virus (HCV) medication in HCV-negative recipients of kidneys from HCV-positive donors. Participants will be randomized into two groups: one receiving a short course of medication before the transplant and the other starting treatment after the transplant for a full course. The medication used is sofosbuvir/velpatasvir, a direct-acting antiviral that has shown high efficacy in curing HCV. The goal is to compare the effectiveness of these two approaches in preventing HCV infection post-transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting
• Loma Linda University Health
  Loma Linda, California, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD
• Email: cdurand2@jhmi.edu
• Phone: 410-955-5684

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.