A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
NCT ID: NCT04075916
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
201 participants
INTERVENTIONAL
2021-06-22
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epclusa (sofosbuvir/velpatasvir)
Epclusa is taken by mouth for 12 weeks as per the FDA label.
Epclusa
All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.
Interventions
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Epclusa
All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.
Eligibility Criteria
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Inclusion Criteria
* Active waiting list status for isolated kidney transplant
* 18 years of age or older
* No living kidney donor
* Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be included unless patient has a most recent cytotoxic PRA of \>25% or calculated PRA \>50% where multiple moderate level HLA antibodies exist and in the opinion of the local site investigator represents substantial HLA sensitization. If patient has a PRA of 98-100%, the donor-recipient pair must meet additional eligibility criteria.
Exclusion Criteria
* Hepatitis B surface antigen and/or DNA positive
* Active Hepatitis C infection
* HIV RNA-positive or HIV antibody positive
* Other chronic liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\] with normal liver enzymes)
* Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)
* Advanced hepatic fibrosis or cirrhosis
* Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist
* Current use of amiodarone or dronedarone (due to interaction with sofosbuvir)
* Transplant candidate requires antibody desensitization protocol for transplantation
* Female who is pregnant, planning to become pregnant during the study, or breast-feeding
* Participation in another interventional study, from a period starting 6 months prior to screening to last study visit, that the study PIs judge would interfere with either the aims or the safety of the THINKER-NEXT study.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Peter Reese, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Florida
Gainesville, Florida, United States
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York Presbyterian Hospital/Columbia University
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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10067385
Identifier Type: -
Identifier Source: org_study_id
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