385
Participants
Start Date
December 20, 2018
Primary Completion Date
March 21, 2025
Study Completion Date
March 21, 2025
tocilizumab
6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.
Placebo
The placebo is 0.9% sterile normal saline. 6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.
Standard of Care Triple IS
"Standard of care triple maintenance IS includes:~1. A calcineurin inhibitor-tacrolimus (Prograf ®) per site standards by sublingual, oral or intravenous route to attain target trough levels.~ Exception: Should a participant be unable to tolerate tacrolimus, the site physician investigator may choose cyclosporine treatment.~2. An anti-proliferative treatment-mycophenolate mofetil or Myfortic® (enteric-coated mycophenolate sodium) will be administered, per protocol.~ Exception: Should a participant be unable to tolerate mycophenolate mofetil, the site physician investigator may choose an alternative treatment.~3. Steroids-methylprednisolone/prednisone dosing will be given according to the local center standard of practice early post transplantation. After 6 months, prednisone may be withdrawn at the discretion of the site physician investigator, per protocol."
Mount Sinai Medical Center (NYMS), New York
Columbia University Medical Center (NYCP), New York
Montefiore Medical Center (NYMA), The Bronx
Allegheny General Hospital (PAAG), Pittsburgh
Penn State Health: Milton S. Hershey Medical Center (PAHE), Hershey
Hospital of the University of Pennsylvania (PAUP), Philadelphia
Duke University Medical Center (NCDU), Durham
Tampa General Hospital (FLTG), Tampa
Vanderbilt University Medical Center (TNVU), Nashville
Cleveland Clinic Foundation (OHCC), Cleveland
Northwestern Memorial Hospital (INLM), Chicago
St. Luke's Hospital of Kansas City (MOLH), Kansas City
University of Nebraska Medical Center (NEUN), Omaha
Baylor University Medical Center (TXTX), Dallas
University of Utah (UTMC), Salt Lake City
Cedars Sinai Medical Center (CACS), Beverly Hills
University of California, San Diego: Sulpizio Cardiovascular Center (CASD), La Jolla
Stanford Health Care (CASU), Stanford
Tufts Medical Center (MANM), Boston
Massachusetts General Hospital (MAMG), Boston
Collaborators (1)
PPD Development, LP
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH