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Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

Primary Purpose

Kidney Failure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kidney Transplantation
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring HCV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • Age 18 and older
  • English and Spanish speaking patients
  • Active on the waiting list for kidney transplantation
  • Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
  • HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Participants co-infected with HIV
  • Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
  • Known allergies or hypersensitivity to DAA or RBV
  • Pregnancy and/or actively breastfeeding

Sites / Locations

  • Loma Linda University Health-Transplant Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recipient of HCV positive kidney graft

Arm Description

A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).

Outcomes

Primary Outcome Measures

1-year graft and patient survival
Will track subjects post transplant for 12 months

Secondary Outcome Measures

Full Information

First Posted
October 25, 2020
Last Updated
August 15, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04605679
Brief Title
Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients
Official Title
Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recipient of HCV positive kidney graft
Arm Type
Experimental
Arm Description
A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).
Intervention Type
Procedure
Intervention Name(s)
Kidney Transplantation
Intervention Description
A HCV negative or previously successfully treated recipient with a HCV positive kidney graft
Primary Outcome Measure Information:
Title
1-year graft and patient survival
Description
Will track subjects post transplant for 12 months
Time Frame
From the date of transplant through the last day of 12 month post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Age 18 and older English and Spanish speaking patients Active on the waiting list for kidney transplantation Donor organ with Antibody and NAT (nucleic acid test) positive for HCV HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy. Willing and able to provide written informed consent Exclusion Criteria: Participants co-infected with HIV Donor previously treated with an NS5a containing regimen (if treatment history of donor known) Known allergies or hypersensitivity to DAA or RBV Pregnancy and/or actively breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E de Vera, MD
Organizational Affiliation
Loma Linda University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health-Transplant Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30083748
Citation
Reese PP, Abt PL, Blumberg EA, Van Deerlin VM, Bloom RD, Potluri VS, Levine M, Porrett P, Sawinski D, Nazarian SM, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Gentile C, Smith J, Niknam BA, Bleicher M, Reddy KR, Goldberg DS. Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients: A Single-Group Trial. Ann Intern Med. 2018 Sep 4;169(5):273-281. doi: 10.7326/M18-0749. Epub 2018 Aug 7.
Results Reference
background
PubMed Identifier
29507971
Citation
Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30083748
Description
Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients
URL
https://pubmed.ncbi.nlm.nih.gov/29507971
Description
Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients

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Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

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