Status:
COMPLETED
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Lead Sponsor:
MedImmune LLC
Conditions:
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Renal allograft recipients receiving their first or second allograft
- Age over 18
- Maintained on conventional immunosuppression
- Completed informed consent document
Exclusion
- 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
Key Trial Info
Start Date :
February 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1998
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00807794
Start Date
February 1 1997
End Date
January 1 1998
Last Update
December 12 2008
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
2
Indiana University
Bloomington, Indiana, United States, 47405
3
San Antonio Community Hospital
San Antonio, Texas, United States, 78229
4
University of Virginia
Charlottesville, Virginia, United States, 22908