A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

Completed · Phase 1

Conditions studied: Kidney Diseases

In brief

To evaluate the clinical safety of different doses of MEDI-507 through day 33.

Key facts

Study ID

NCT00807794

Run by

MedImmune LLC

People needed

13

Starts

1997-02-01

Expected to finish

1998-01-01

Last updated by the study team

2008-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Renal allograft recipients receiving their first or second allograft
• Age over 18
• Maintained on conventional immunosuppression
• Completed informed consent document

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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