Title
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Phase
Phase 1Lead Sponsor
MedImmuneStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Kidney DiseasesIntervention/Treatment
siplizumab ...Study Participants
13To 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.
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
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)
Inclusion Criteria: Renal allograft recipients receiving their first or second allograft Age over 18 Maintained on conventional immunosuppression Completed informed consent document Exclusion Criteria: Known hypersensitivity to MEDI-507 More than two renal allografts Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert) Any of the following clinical settings or diagnoses posttransplant: pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft Less than 10 ml/hr average urine output over 4 hours since the end of surgery
