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

ConditionHCV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

Qualifiers

Participant meets the standard criteria for KT at local center.

Participant is able to understand and provide informed consent.

Participant is ≥ 18 years old.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Prophylaxis (P2W)
  • Transmit and Treat (T&T)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator