A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Gilead Sciences National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Sofosbuvir-velpatasvir drug combination Velpatasvir