To evaluate the clinical safety of different doses of MEDI-507 through day 33.
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Yale University School of Medicine
New Haven, Connecticut, United States
Indiana University
Bloomington, Indiana, United States
San Antonio Community Hospital
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
Time frame: Day 33
To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
Time frame: Day 33
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0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)