Utilization of Hepatitis C Positive Kidneys in Negative Recipients

August 30, 2023 updated by: Reem Daloul, Ohio State University

An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Brenda Cuson

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

Description

Recipient Inclusion/Exclusion Criteria:

Inclusion Criteria:

  • Adult age >18 years able to provide consent
  • Lack of available living donor
  • Calculated pre-transplant reactive panel (cPRA) of <80%
  • Estimated post-transplant survival (EPTS) index >20% and <80%
  • Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
  • No clinically significant pre-transplant liver disease

Exclusion Criteria:

  • Living donor available
  • Dialysis time >5 years
  • Listing for multi-organ transplantation
  • Active or recent history (<6 months) of alcohol abuse or substance abuse
  • Clinically significant liver disease as determined by principal investigator
  • History of hepatocarcinoma
  • Pregnancy or lactation
  • Refusal to accept blood transfusion
  • HIV infection
  • HCV pcr or antibody positive
  • HBV infection

Donor Inclusion Criteria:

  • Positive HCV PCR at time of donation
  • Kidney donor profile index (KDPI)<85%

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Other Names:
  • Epclusa
Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
Three tablets once a day for 12 weeks for treatment of hepatitis C
Other Names:
  • Mavyret

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
Time Frame: 12 weeks
Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.
12 weeks
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
Time Frame: 12 weeks
Elevation in liver enzyme >5 times the upper limits, development of acute cholestatic hepatitis , or intolerance to Direct acting antiviral therapies was to test the safety of utilizing HepC positive kidneys for transplant.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant
Time Frame: 6 and 12 months
Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys.
6 and 12 months
Patient's Survival at 6 and 12 Months
Time Frame: 6 and 12 months
Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys.
6 and 12 months
Graft Survival at 6 and 12 Months
Time Frame: 12 months
Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys.
12 months

Collaborators and Investigators

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

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Reem Daloul, MD, Ohio State University School of Biomedical Science: The Ohio State University College of Medicine

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

Helpful Links

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)

March 22, 2019

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018H0499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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