Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Raymond Chung
With
AbbVie
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Weill Medical College of Cornell University
University of Michigan
Northwestern University
The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.
Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
No available medically acceptable, compatible living kidney donor
Subject must agree to use an effective method of birth control per protocol specifications
Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
HCV RNA-positive
You may not be if
History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
History of HIV
HCV RNA positive
HBV surface Ag-positive or detectable HBV DNA
Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
Presence of clinically significant liver disease
Transplant candidate requiring antibody desensitization protocol for transplantation
Most recent calculated panel reactive antibody (cPRA) \>80%.
Prior recipient of a non-renal solid organ transplant
Known prior HCV treatment with direct acting antiviral medication
HIV RNA-positive
HBV Surface antigen-positive or HBV DNA-positive
Clareo Health | Multi-center Study to Transplant Hepatitis-C Infected Kidneys
