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

NCT04075916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2026-03-12

No results posted yet for this study

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

Interventions

DRUG

Epclusa

All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.

Sponsors & Collaborators

Principal Investigators

  • Peter Reese, MD, PhD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2025-07-15
Completion
2026-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075916 on ClinicalTrials.gov