Status:
ACTIVE_NOT_RECRUITING
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Gilead Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2026
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04075916
Start Date
June 22 2021
End Date
January 30 2026
Last Update
October 8 2025
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Florida
Gainesville, Florida, United States, 32608
3
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States, 33136
4
Johns Hopkins
Baltimore, Maryland, United States, 21287