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Purpose

The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The survival rate of patients opting-in for offers of kidneys from HCV-viremic donors will be compared to the survival rate of matched comparators from the kidney transplant waitlist who did not consent to receive offers of a HCV-viremic kidney. Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able to provide informed consent - 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

  • Hepatocellular carcinoma - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Epclusa (sofosbuvir/velpatasvir) 		Epclusa is taken by mouth for 12 weeks as per the FDA label.
  • Drug: Epclusa
    All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Shikha Mehta, MD
smehta@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Peter Reese, MD, PhD
(307) 22-THINK
thinker@med.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.