Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Loma Linda University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- 1-year graft and patient survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Recipient of HCV positive kidney graft
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).
Intervention: Kidney Transplantation (Procedure)
Outcomes
Primary Outcomes
1-year graft and patient survival
Time Frame: From the date of transplant through the last day of 12 month post transplant
Will track subjects post transplant for 12 months
Secondary Outcomes
No secondary outcomes reported