200
Participants
Start Date
May 22, 2024
Primary Completion Date
June 30, 2028
Study Completion Date
June 30, 2028
Sirolimus
Participants in Group 1 will transition to sirolimus therapy on day 14 (+/- 5 days) - weight \<40 kg will receive 3mg/m\^ 2, with maintenance dose of 1 mg/m\^2 divided BID - weight \>= 40kg will receive 6mg/m\^ 2, with maintenance dose of 2 mg daily
Belatacept
Belatacept will be administered as an intravenous infusion over 30 minutes. The belatacept dose for the study is 10 mg/kg on post-operative day (POD) 1, 5, 14, 28, 56, 84 for the first 3 months, followed by 5 mg/kg every 4 weeks (+/-4 days), starting on month 4 until month 24
Mycophenolate Mofetil
Mycophenolate Mofetil-MMF will be initiated at 600 mg/m\^2 BID until tacrolimus is at therapeutic levels, then 450 mg/m\^2 BID
Tacrolimus (Group1)
Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels. Participants in Group 1 will be transitioned to sirolimus 2-4 weeks post-transplant
Anti-Thymocyte Globulin (ATG)
Participants will receive induction therapy with anti-thymocyte globulin (1.5 mg/kg/dose, maximum 125 mg) starting intraoperatively on day 0 and continuing on days 2 and 3 (total dose 4.5 mg/kg). Total dose may be extended to 6 mg/kg over 1-2 days for delayed graft function
Tacrolimus (Group 2)
Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels
NOT_YET_RECRUITING
New York Medical College/Boston Children's Health Physicians, Westchester
RECRUITING
UPMC Children's Hospital of Pittsburgh (Site #: 71008), Pittsburgh
RECRUITING
Children's Hospital of Philadelphia (Site #: 71091), Philadelphia
RECRUITING
Nemours Children's Health (Site #: 71042), Wilmington
RECRUITING
Children's National Medical Center (Site #: 71039), Washington D.C.
RECRUITING
Johns Hopkins Children's Center (Site #: 71025), Baltimore
RECRUITING
Duke University (Site #: 71033), Durham
RECRUITING
University of Alabama at Birmingham (Site # 71038), Birmingham
RECRUITING
Cincinnati Children's Hospital Medical Center (Site #: 71017), Cincinnati
RECRUITING
Helen DeVos Children's Hospital (Site #: 71035), Grand Rapids
RECRUITING
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016), Chicago
RECRUITING
Washington University/St. Louis Children's Hospital (Site #: 71006), St Louis
RECRUITING
Texas Children's Hospital (Baylor) (Site #: 71005), Houston
RECRUITING
Children's Hospital of Colorado (Site #: 71019), Aurora
NOT_YET_RECRUITING
Children's Hospital of Los Angeles (Site #: 71036), Los Angeles
RECRUITING
Cedars-Sinai Medical Center (Site #: 71026), Los Angeles
RECRUITING
Mattel Children's Hospital, UCLA (Site #: 71012), Los Angeles
RECRUITING
UCSD Rady Children's Hospital (Site #: 71037), San Diego
RECRUITING
Seattle Children's Hospital (Site #: 71041), Seattle
RECRUITING
Boston Children's Hospital (Site #: 71001), Boston
National Institute of Allergy and Infectious Diseases (NIAID)
NIH