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

NCT03809533 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-06

No results posted yet for this study

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

Interventions

DRUG

sofosbuvir/velpatasvir

12-week, oral, fixed-dose

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Amit D Tevar, MD

    lead OTHER

Principal Investigators

  • Amit Tevar, MD · University of Pittsburgh

  • Fernanda Silviera, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809533 on ClinicalTrials.gov