Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients
Not Applicable
Active, not recruiting
- Conditions
- Kidney Failure
- 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
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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Loma Linda University Health-Transplant Institute
🇺🇸Loma Linda, California, United States
Loma Linda University Health-Transplant Institute🇺🇸Loma Linda, California, United States