Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Other
Disease
Hepatitis C
Enrollment Eligibility
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 (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