Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
With
Gilead Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to provide informed consent
Active waiting list status for isolated kidney transplant
18 years of age or older
No living kidney donor
Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be included unless patient has a most recent cytotoxic PRA of \>25% or calculated PRA \>50% where multiple moderate level HLA antibodies exist and in the opinion of the local site investigator represents substantial HLA sensitization. If patient has a PRA of 98-100%, the donor-recipient pair must meet additional eligibility criteria.
You may not be if
Hepatocellular carcinoma
Hepatitis B surface antigen and/or DNA positive
Active Hepatitis C infection
HIV RNA-positive or HIV antibody positive
Other chronic liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\] with normal liver enzymes)
Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)
Advanced hepatic fibrosis or cirrhosis
Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist
Current use of amiodarone or dronedarone (due to interaction with sofosbuvir)
Transplant candidate requires antibody desensitization protocol for transplantation
Female who is pregnant, planning to become pregnant during the study, or breast-feeding
Participation in another interventional study, from a period starting 6 months prior to screening to last study visit, that the study PIs judge would interfere with either the aims or the safety of the THINKER-NEXT study.
