32
Participants
Start Date
September 20, 2016
Primary Completion Date
August 4, 2023
Study Completion Date
August 4, 2023
Polyclonal Regulatory T Cells
Participants randomized to polyTregs group will receive a single infusion of 550 ± 450 x 10\^6 polyTregs.
Everolimus
Tacrolimus
Mycophenolate mofetil
All enrolled participants will be on MMF (or MPA below) at the time of study entry at a minimum dose of 1000mg per day.
Mycophenolic acid
All enrolled participants will be on MPA (or MMF above) at the time of study entry at a minimum dose of 720mg per day.
Acetaminophen
650 mg acetaminophen, administered 30-60 minutes prior to infusion as pre-medication.
Diphenhydramine
25-50 mg diphenhydramine intravenously or by mouth, administered 30-60 minutes prior to infusion as pre-medication.
Biopsy, Kidney
Blood Draw
Leukapheresis
IS regimen conversion
Conversion from Tacrolimus, a calcineurin inhibitors (CNI), to Everolimus, an mTOR inhibitor.
University of Alabama, Birmingham, Birmingham
Cleveland Clinic, Cleveland
University of Michigan, Ann Arbor
Northwestern University Comprehensive Transplant Center, Chicago
University of Colorado Health Transplant Center - Anschutz, Aurora
University of California at San Francisco, San Francisco
Clinical Trials in Organ Transplantation
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH