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

NCT ID: NCT00807794

Last Updated: 2008-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

1998-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MEDI-507

Group Type EXPERIMENTAL

MEDI-507

Intervention Type DRUG

0.012 mg/kg dose given twice between 60 to 72 hours apart

2

MEDI-507

Group Type EXPERIMENTAL

MEDI-507

Intervention Type DRUG

0.06 mg/kg dose given twice between 60 to 72 hours apart

3

MEDI-507

Group Type EXPERIMENTAL

MEDI-507

Intervention Type DRUG

0.12 mg/kg dose given twice between 60 to 72 hours apart

4

MEDI-507

Group Type EXPERIMENTAL

MEDI-507

Intervention Type DRUG

0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

5

MEDI-507

Group Type EXPERIMENTAL

MEDI-507

Intervention Type DRUG

0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

Interventions

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MEDI-507

0.012 mg/kg dose given twice between 60 to 72 hours apart

Intervention Type DRUG

MEDI-507

0.06 mg/kg dose given twice between 60 to 72 hours apart

Intervention Type DRUG

MEDI-507

0.12 mg/kg dose given twice between 60 to 72 hours apart

Intervention Type DRUG

MEDI-507

0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

Intervention Type DRUG

MEDI-507

0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Medimmune Inc.

Principal Investigators

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J. Bruce McClain, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Indiana University

Bloomington, Indiana, United States

Site Status

San Antonio Community Hospital

San Antonio, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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MI-CP027

Identifier Type: -

Identifier Source: org_study_id