CompletedPhase 2

A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

United States201 participantsStarted 2021-06-22

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, o…

What they're measuring

Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA)

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT04075916

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15