HCV + to HCV - Kidney Transplant

August 29, 2022 updated by: Nahel Elias, M.D., Massachusetts General Hospital

Hepatitis C Viral Kidneys Used for Non-Viremic Recipients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Direct Acting Antiviral for HCV
8 weeks of treatment with HCV Direct Acting Antiviral tablet
Drug: Direct Acting Antivirals
8 weeks of DAA treatment
Other Names:
  • Direct Acting Antiviral HCV Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable HCV RNA
Time Frame: 12 weeks post-treatment
Negative HCV RNA 12 weeks after last dose of treatment
12 weeks post-treatment
Rate of Serious and non-serious adverse events
Time Frame: 1 year post-transplant
Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment
1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Actual)

June 16, 2020

Study Completion (Actual)

June 16, 2020

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P000374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anticipate to share coded data with collaborators

IPD Sharing Time Frame

Ancicipate data would be available to share by 6 months are the final patient visit.

IPD Sharing Access Criteria

Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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