HCV Prophylaxis Strategies for Kidney Transplant Recipients (PREVENT-HCV Trial)

N/A

Recruiting

Led By Christine Durand, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the first year post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two approaches to treating HCV in kidney transplant recipients.

Who is the study for?

This trial is for adults over 18 who need a kidney transplant and can give informed consent. They must meet standard criteria for transplantation, have normal liver function (AST or ALT within safe limits), and not be infected with HIV, active hepatitis B, or have had hepatitis C. Pregnant or breastfeeding individuals are excluded.

What is being tested?

The study compares two timings to start Hepatitis C medication in patients receiving kidneys from HCV-positive donors: 'Prophylaxis' starts treatment before the transplant with a shorter course of medication; 'Transmit and Treat' begins after the transplant with a full course.

What are the potential side effects?

Potential side effects of the Hepatitis C medications used in this trial may include headache, fatigue, nausea, difficulty sleeping, low blood count (anemia), elevated liver enzymes indicating liver injury, rash, itching skin (pruritus), and gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the first year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the first year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the first year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse

Number of participants with liver injury

Secondary study objectives

Development of HCV resistance-associated variants (RAVs)

Graft function - eGFR <60

Graft function - eGFR slope

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transmit and Treat (T&T)Experimental Treatment1 Intervention

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.

Group II: Prophylaxis (P2W)Experimental Treatment1 Intervention

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

Do I qualify?Apply below to find out