80
Participants
Start Date
November 23, 2021
Primary Completion Date
February 28, 2025
Study Completion Date
February 28, 2025
Twice-daily Tacrolimus
Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.
Once-daily envarsus XR
Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
Methylprednisolone, prednisone
Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.
Azathioprine
Azathioprine (1-3 mg/kg) will be administered once a day.
RECRUITING
University of Southern California, Los Angeles
Collaborators (1)
Veloxis Pharmaceuticals
INDUSTRY
University of Southern California
OTHER