Preventing Hepatitis C in Kidney Transplant Recipients from Infected Donors

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: a Randomized Controlled Trial

This study is testing whether starting Hepatitis C medication before or after a kidney transplant from an infected donor can better prevent infection in kidney transplant recipients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 9 sites (La Jolla, California and 8 other locations)
• Trial ID: NCT05653232 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are HCV-negative adults who meet the standard criteria for kidney transplantation.

Not a fit: Patients with active HCV infection, cirrhosis, or other significant liver conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer transplantation option for patients receiving kidneys from HCV-positive donors.

How similar studies have performed: Previous studies have shown success with similar antiviral approaches in treating HCV, making this a promising area of investigation.

Eligibility criteria

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 this trial is running

La Jolla, California and 8 other locations

• 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)
• University of Utah Medical Center — Salt Lake City, Utah, United States (RECRUITING)
• Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
• University of Wisconsin, Madison — Madison, Wisconsin, United States (TERMINATED)

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD

Conditions: HCV