The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

NCT03809533 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY19100135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Conditions

Kidney Transplantation; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group

  5 years

• HCV free at 1 year

  Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation

  1 year

Secondary Outcomes (5)

• Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients

  5 years

• Incidence of allograft rejection

  5 years

• Incidence of graft loss

  5 years

• All-cause mortality

  5 years

• Waitlist time after enrollment

  5 years

Study Arms (2)

HCV seropositive non-viremic (HCV Ab+/NAT-) donor

EXPERIMENTAL

Kidney recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

HCV seropositive viremic (HCV Ab+/NAT+) donor

EXPERIMENTAL

Starting post-operative day 1, kidney recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Drug: sofosbuvir/velpatasvir

Interventions

sofosbuvir/velpatasvir DRUG

12-week, oral, fixed-dose

Also known as: Epclusa

HCV seropositive viremic (HCV Ab+/NAT+) donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage renal disease listed for kidney transplantation at UPMC.
• On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \< 15 ml/min
• Age ≥ 18
• No available living kidney donor
• Listed for an isolated kidney transplant at UPMC with \<60m of accrued transplant waiting time and/or \<60m of dialysis time
• Have panel reactive antibody level of \<98%
• No obvious contraindication to kidney transplant
• Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
• Able to provide informed consent
• Be willing to use a contraceptive method for a year after transplant

You may not qualify if:

• HIV positive
• HCVAb or HCV RNA positive
• Presence of behavioral risk factors for contracting HCV other than being on hemodialysis. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
• Hepatitis B surface antigen positive
• History of liver cirrhosis
• Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
• History of atrial fibrillation requiring the use of amiodarone over the past 12m
• Patients with etiology of renal failure with increased risk of causing early graft failure as assessed by the investigator team
• Receipt of prior organ transplant
• Waitlisted for a multi-organ transplant
• Pregnant women
• Known allergy to sofosbuvir/velpatasvir
• Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
• HCV antibody positive
• HCV NAT negative or positive

Sponsors & Collaborators

• Amit D Tevar, MD: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Amit Tevar, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Fernanda Silviera, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: May 29, 2019
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)