A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
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
- End Stage Renal Disease
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Epclusa (sofosbuvir/velpatasvir) |
Epclusa is taken by mouth for 12 weeks as per the FDA label. |
|
Recruiting Locations
Nashville, Tennessee 37235
More Details
- Status
- Recruiting
- Sponsor
- University of Pennsylvania