- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807794
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
December 10, 2008 updated by: MedImmune LLC
Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale University School Of Medicine
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Indiana University
-
-
Texas
-
San Antonio, Texas, United States, 78229
- San Antonio Community Hospital
-
-
Virginia
-
Charlottesville,, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
MEDI-507
|
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
|
Experimental: 2
MEDI-507
|
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
|
Experimental: 3
MEDI-507
|
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
|
Experimental: 4
MEDI-507
|
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
|
Experimental: 5
MEDI-507
|
0.012 mg/kg dose given twice between 60 to 72 hours apart
0.06 mg/kg dose given twice between 60 to 72 hours apart
0.12 mg/kg dose given twice between 60 to 72 hours apart
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: Day 33
|
Day 33
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
Time Frame: Day 33
|
Day 33
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: J. Bruce McClain, M.D., MedImmune LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1997
Primary Completion (Actual)
November 1, 1997
Study Completion (Actual)
January 1, 1998
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (Estimate)
December 12, 2008
Study Record Updates
Last Update Posted (Estimate)
December 12, 2008
Last Update Submitted That Met QC Criteria
December 10, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-CP027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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