290
Participants
Start Date
November 2, 2015
Primary Completion Date
July 23, 2021
Study Completion Date
July 23, 2021
Infliximab
A single dose, of 3mg/kg infusion
Methylprednisolone
500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
Mycophenolate Mofetil
Administered at a target dose of 2000mg daily, as tolerated, until study closure
Tacrolimus
Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
Thymoglobulin®
Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
Acetaminophen
"30 to 60 minutes prior to the start of the infusion~* Tylenol, 600 to 1000mg by mouth or~* Suppository form"
Loratadine
"30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth"
Placebo for Infliximab
A single dose is volume matched to Infliximab (250mL) infusion
Prednisone
Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
Diphenhydramine
"30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth"
Mount Sinai Medical Center, New York
University of Maryland, Baltimore
Johns Hopkins University, Baltimore
Emory University, Atlanta
University of Alabama at Birmingham, Birmingham
Cleveland Clinic, Cleveland
University Hospitals of Cleveland, Cleveland
University of Michigan, Ann Arbor
University of Wisconsin, Madison
Washington University School of Medicine in St. Louis, St Louis
University of California, Los Angeles, Los Angeles
University of California, San Francisco, San Francisco
Yale University, New Haven
University of Manitoba, Winnipeg
Toronto General Hospital, Toronto
Clinical Trials in Organ Transplantation
NETWORK
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH