Kidney Failure
Conditions
Keywords
HCV
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.
Interventions
PROCEDUREKidney Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive kidney graft
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael E de Vera, MD
Loma Linda University Health
Outcome results
None listed