35
Participants
Start Date
January 31, 2005
Primary Completion Date
November 30, 2009
Study Completion Date
November 30, 2009
Alemtuzumab
Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.
Tacrolimus
Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
Mycophenolate mofetil
Per recommendation
Sirolimus
Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
Children's Hospital, Philadelphia, Philadelphia
Children's Hospital and Regional Medical Center, Seattle, Seattle
University of California, San Francisco, San Francisco
Children's Hospital, Boston, Boston
Cooperative Clinical Trials in Pediatric Transplantation
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH