163
Participants
Start Date
February 9, 2022
Primary Completion Date
April 1, 2027
Study Completion Date
May 31, 2027
High-dose methylprednisolone
Subjects in the high-dose methylprednisolone arm will receive an initial dose of methylprednisolone IV 10 mg/kg/day for 3 days and 5 mg/kg/day on Day 4. Normal saline will be used as placebo pre-medications and infusions given at the same volume and duration as the eATG infusions.
Equine anti-thymocyte globulin
Subjects will receive eATG IV 40 mg/kg/day on Days 1- 4. Day 1 eATG infusion is run over 8 hours and Day 2-4 infusions are run over 4 hours.
Prednisolone
"Subjects will receive prednisolone 1 mg/kg on Days 5-13 followed by a gradual taper with discontinuation at 42 Days as indicated below.~Days 5 - 13 Prednisolone PO 1 mg/kg/day (max 50 mg/day)~Days 14- 20 Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)~Days 21 - 27 Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)~Days 28 - 34 Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)~Days 35 - 41 Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)~Day 42 Discontinue"
Placebo for prednisolone
"Subjects will receive 1 mg/kg/day of oral placebo for prednisolone on days 5-13 followed by a gradual taper to discontinuation at 42 days as indicated below. Subjects receiving oral placebo will be given a solution that closely resembles the treatment drug.~Days 5 - 13 Placebo for Prednisolone PO 1 mg/kg/day (max 50 mg/day)~Days 14- 20 Placebo for Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)~Days 21 - 27 Placebo for Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)~Days 28 - 34 Placebo for Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)~Days 35 - 41 Placebo for Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)~Day 42 Discontinue"
Placebo for infusions
Subjects randomized to the supportive care alone arm will receive normal saline in place of all study treatments (skin test, premedication and IV infusions) on Days 1-4 given at the same volume and duration as the eATG infusions.
Diphenhydramine
Subjects in the eATG arm will receive pre-treatment medication diphenhydramine IV 1 mg/kg prior to start of eATG infusion.
Methylprednisolone
Subjects in the eATG arm will receive pre-treatment medication methylprednisolone IV 1 mg/kg prior to start of eATG infusion.
WITHDRAWN
The Mount Sinai Medical Center, New York
RECRUITING
NYP Morgan Stanley Children's Hospital, New York
RECRUITING
Children's Hospital of Pittsburgh, Pittsburgh
RECRUITING
The Children's Hospital of Philadelphia, Philadelphia
WITHDRAWN
Duke University Medical Center - Duke Children's, Durham
RECRUITING
Children's Healthcare of Atlanta - Arthur M. Blank Hospital, Atlanta
RECRUITING
Cleveland Clinic Children's, Cleveland
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
Riley Hospital for Children, Indianapolis
RECRUITING
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
RECRUITING
St. Louis Children's Hospital, St Louis
RECRUITING
The Children's Mercy Hospital, Kansas City
RECRUITING
UT Southwestern Medical Center Children's Health, Dallas
RECRUITING
Texas Children's Hospital, Houston
RECRUITING
Children's Hospital Colorado, Aurora
WITHDRAWN
Primary Children's Medical Center, Salt Lake City
RECRUITING
Children's Hospital Los Angeles, Los Angeles
RECRUITING
Rady Children's Hospital, San Diego
WITHDRAWN
University of California San Francisco Benioff Children's Hospital, San Francisco
RECRUITING
Lucile Packard Children's Hospital, Palo Alto
RECRUITING
Seattle Children's Hospital, Seattle
WITHDRAWN
Yale New Haven Children's Hospital, New Haven
RECRUITING
Children's Hospital Boston, Boston
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH