Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2025-12-31

Brief Summary

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To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

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Detailed Description

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Conditions

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Kidney Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recipient of HCV positive kidney graft

A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).

Group Type EXPERIMENTAL

Kidney Transplantation

Intervention Type PROCEDURE

A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

Interventions

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Kidney Transplantation

A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age 18 and older
* English and Spanish speaking patients
* Active on the waiting list for kidney transplantation
* Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent

Exclusion Criteria

* Participants co-infected with HIV
* Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to DAA or RBV
* Pregnancy and/or actively breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No