A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (THINKER-NEXT)

  • STATUS
    Recruiting
  • End date
    Dec 15, 2025
  • participants needed
    400
  • sponsor
    University of Pennsylvania
Updated on 15 October 2022

Summary

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 mortality rate of kidney transplant candidates who enroll in THINKER-NEXT and consent to offers of kidneys from HCV-infected donors will be compared to matched wait-listed patients who do not consent to receive HCV-infected kidneys (these patients are called Wait-list Cohort). Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.

Details
Condition End Stage Renal Disease
Treatment Epclusa
Clinical Study IdentifierNCT04075916
SponsorUniversity of Pennsylvania
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to provide informed consent
Active waiting list status for isolated kidney transplant
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
Active Hepatitis C infection
Hepatitis B surface antigen and/or DNA positive
HIV RNA-positive or HIV antibody positive
Other chronic liver disease (excluding non-alcoholic fatty liver disease [NAFLD] with normal liver enzymes)
Advanced hepatic fibrosis or cirrhosis
Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)
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 (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 of any investigational agent or approved medication, or participation in another kind interventional study that the responsible investigator deems to be an exclusion from period 6 months prior to screening to last study visit
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