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

• Status: Completed
• Trial end date: 1998-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC

Criteria

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