drugset / Trial / NCT04075916

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

NCT04075916

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-06-22
Primary completion
2025-07-15
Completion
2026-02-25

Drugs

EvaluationDrugModalityDoseRoute
Subject glecaprevir Other / unclassified Oral