Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

Not Applicable

Active, not recruiting

• Conditions: Kidney Failure
• Interventions: Procedure: Kidney Transplantation

• Registration Number: NCT04605679
• Lead Sponsor: Loma Linda University

Brief Summary

To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Male or female
• Age 18 and older
• English and Spanish speaking patients
• Active on the waiting list for kidney transplantation
• Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
• HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
• Willing and able to provide written informed consent

Exclusion Criteria

• Participants co-infected with HIV
• Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
• Known allergies or hypersensitivity to DAA or RBV
• Pregnancy and/or actively breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recipient of HCV positive kidney graft	Kidney Transplantation	A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).

Primary Outcome Measures

Name	Time	Method
1-year graft and patient survival	From the date of transplant through the last day of 12 month post transplant	Will track subjects post transplant for 12 months

Trial Locations

Locations (1)

Loma Linda University Health-Transplant Institute; 🇺🇸 Loma Linda, California, United States