NCT04075916

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Epclusa	All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.

Timeline

• Start date: 2021-06-22
• Primary completion: 2025-07-15
• Completion: 2026-02-25
• First posted: 2019-09-03
• Last updated: 2026-03-12

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study