A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
- Registration Number
- NCT00807794
- Lead Sponsor
- MedImmune LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5 MEDI-507 MEDI-507 1 MEDI-507 MEDI-507 2 MEDI-507 MEDI-507 3 MEDI-507 MEDI-507 4 MEDI-507 MEDI-507
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
San Antonio Community Hospital
🇺🇸San Antonio, Texas, United States
Indiana University
🇺🇸Bloomington, Indiana, United States
University of Virginia
🇺🇸Charlottesville,, Virginia, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States