HCV + to HCV - Kidney Transplant

Phase 4WithdrawnNCT04320290

Massachusetts General Hospital

Overview

This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Kidney Failure Hepatitis C

Interventions

Direct Acting AntiviralsDRUG

8 weeks of DAA treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Recipient Inclusion Criteria: * Met MGH transplant center criteria and already listed for kidney transplant * Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method * No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team * Able to sign informed consent Recipient Exclusion Criteria: * Pregnant or nursing (lactating) women * HBV positivity (Ag or DNA) * Any contra-indication to kidney transplantation per center protocol Donor Inclusion Criteria * Detectable HCV NAT test * KDPI score is less than ≤ 0.850 * Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Donor Exclusion Criteria * Confirmed HIV * Confirmed HBV positive (surface antigen or HBV DNA positive) * Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Outcomes

Primary Outcomes

Undetectable HCV RNA

Negative HCV RNA 12 weeks after last dose of treatment

Time frame: 12 weeks post-treatment

Rate of Serious and non-serious adverse events

Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment

Time frame: 1 year post-transplant

Data from ClinicalTrials.gov

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