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

Sponsor
Loma Linda University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04605679
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
35.8
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Kidney Transplantation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients
Actual Study Start Date :
May 6, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recipient of HCV positive kidney graft

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).

Procedure: Kidney Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

Outcome Measures

Primary Outcome Measures

  1. 1-year graft and patient survival [From the date of transplant through the last day of 12 month post transplant]

    Will track subjects post transplant for 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Health-Transplant Institute Loma Linda California United States 92354

Sponsors and Collaborators

  • Loma Linda University

Investigators

  • Principal Investigator: Michael E de Vera, MD, Loma Linda University Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT04605679
Other Study ID Numbers:
  • 5200098
First Posted:
Oct 28, 2020
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Loma Linda University
HCV
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Nov 17, 2021