46
Participants
Start Date
February 28, 2013
Primary Completion Date
August 31, 2016
Study Completion Date
August 31, 2016
Belatacept
The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).
methylprednisolone
Anti-thymocyte Globulin (Rabbit)
Tacrolimus
There may be an opportunity to withdraw tacrolimus at week 40
Mycophenolate mofetil
Mycophenolate mofetil will be administered at a target dose of 1000 mg by mouth twice daily (e.g., BID) beginning on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed (maximum MMF dosing is 2G per day). MMF will be adjusted based on clinical complications (such as neutropenia). Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Emory University, Atlanta
University of Alabama at Birmingham, Birmingham
Indiana University Hospital, Indianapolis
University of Wisconsin, Madison
University of California San Francisco Medical Center, San Francisco
Collaborators (1)
Clinical Trials in Organ Transplantation
NETWORK
Rho Federal Systems Division, Inc.
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH