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

Kidney Diseases Clinical Trial

Official title:

Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807794
• Other study ID #: MI-CP027
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2008
• Last updated: December 10, 2008
• Start date: February 1997
• Est. completion date: January 1998

Study information

• Verified date: December 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 1998
• Est. primary completion date: November 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Drug:
• MEDI-507
0.012 mg/kg dose given twice between 60 to 72 hours apart
• MEDI-507
0.06 mg/kg dose given twice between 60 to 72 hours apart
• MEDI-507
0.12 mg/kg dose given twice between 60 to 72 hours apart
• MEDI-507
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
• MEDI-507
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

Locations

Country	Name	City	State
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	San Antonio Community Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes