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

University of Pennsylvania

Status and phase

Active, not recruiting

Phase 2

Conditions

End Stage Renal Disease

Treatments

Drug: Epclusa

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT04075916

U01DK126654 (U.S. NIH Grant/Contract)

10067385

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.