Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

March 4, 2022 updated by: Raymond Chung, Massachusetts General Hospital
This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents 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Withdrawn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 patient selected for this study previously received a kidney transplant under protocol 2016P002051. Unfortunately, she experienced primary graft nonfunction due to a renal vein thrombus and acute thrombotic microangiopathy and the transplanted HCV+ kidney was removed. She continued glecaprevir and pibrentasvir for the full course (8 weeks of treatment) and was cured of HCV. However, she continues on dialysis requiring ongoing, albeit low dose, immunosuppression after her failed transplant. This causes increased risk of infection and other dialysis-related morbidity. Futhermore, she is at risk of access loss due to multiple failed fistula attempts and prior dialysis catheter line thrombosis. Of note, she also failed a trial of peritoneal dialysis due to development of a large pleural effusion (a known treatment-limiting complication of peritoneal dialysis). Thus, this young patient, is at risk of losing dialysis access which could lead to death. The MGH transplant team has now decided that she could be retransplanted with alterations in peri-transplant anticoagulation and immunosuppression (eculizumab) that they are confident should decrease her risk of peri-transplant thrombosis and recurrent TMA. Thus, we desire to expedite her access to re-transplant. Through this protocol, this recipient will be given the opportunity to accept a kidney that is HCV antibody positive and nucleic acid test (NAT) negative or HCV NAT positive and will be treated with oral glecaprevir (300mg)/pibrentasvir (120mg) (G/P, MavyretTM) on day 3 (+/- 2 days) post-kidney transplant to prevent the transmission of HCV infection at the time of transplant. Our goal is to provide access to kidney transplantation as soon as possible, with a donor of any genotype of infection, with elimination of the potential HCV infection by therapy used on day 3 (+/- 2 days) in the case of HCV NAT+ transplant and surveillance and reactive therapy in the case of HCV antibody positive NAT- transplant.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

34 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Donor Inclusion Criteria:

  • Detectable HCV Antibody Positivity
  • KDPI score is less than ≤ 0.650
  • Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation at MGH

Donor exclusion criteria

  • Donor has been known to have previously received and failed HCV treatment with a direct-acting antiviral agent
  • Confirmed HIV
  • Confirmed HBV positive (surface antigen or HBV DNA positive)
  • Kidney anatomical damage or significant pathology noted during recovery
  • Significant liver disease or signs of liver decompensation (splenomegaly, ascites) noted during recovery (advanced fibrosis or cirrhosis)
  • Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection)

Recipient Inclusion/Exclusion Criteria

  • Previously enrolled in IRB 2016P002051 and experienced primary graft nonfunction due to renal vein thrombosis and acute thrombotic microangiopathy
  • Willing and able to sign informed consent

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: Experimental: Glecaprevir/pibrentasvir for HCV+ kidney transplant recipient

Glecaprevir (100mg) / pibrentasvir (40mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor.

Subject will receive first dose on day 3 (+/- 2 days) post-kideny transplantation and continue daily for 8 weeks.
Drug: Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]
The subject will begin an 8 week course of therapy with glecaprevir (100mg) / pibrentasvir (40mg) starting on day 3 (+/- 2 days) post-kidney transplantation from a hepatitis C positive donor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C viral load (RNA)
Time Frame: 20 weeks post-transplant (12-weeks post-treatment)
Negative hepatitis C viral load (RNA) tested using PCR at 12 weeks post-treatment (SVR12)
20 weeks post-transplant (12-weeks post-treatment)

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 13, 2020

Primary Completion (Actual)

August 4, 2021

Study Completion (Actual)

August 4, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared outside of the research team.

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.

Yes

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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