Kidney Diseases
Conditions
Brief summary
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Detailed description
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
Interventions
DRUGMEDI-507
0.012 mg/kg dose given twice between 60 to 72 hours apart
Sponsors
MedImmune LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 33 |
Secondary
| Measure | Time frame |
|---|---|
| To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival. | Day 33 |
Countries
United States
Outcome results
None listed