Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT03801707
Collaborator
(none)
30
1
1
25.3
1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
  • Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient
Actual Study Start Date :
Mar 22, 2019
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with undetectable HCV polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment with Sofosbuvir/Velpatasvir [12 weeks]

      Efficacy

    2. The incidence of adverse events related to Sofosbuvir/Velpatasvir drug therapy [12 weeks]

      safety

    Secondary Outcome Measures

    1. Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant [6 and 12 months]

      Safety

    2. Patient's survival at 6 and 12 months [6 and 12 months]

      Safety

    3. Graft survival at 12 months [12 months]

      Safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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), HCV, and hepatitis B virus (HBV) serology and blood HCV 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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brenda Cuson Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Reem Daloul, Assistant Professor of Clinical Medicine, Transplant Nephrology, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT03801707
    Other Study ID Numbers:
    • 2018H0499
    First Posted:
    Jan 11, 2019
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2021