Back to resultsA Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI-507
MEDI-507
MEDI-507
MEDI-507
MEDI-507
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases
Eligibility 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
Sites / Locations
- Yale University School of Medicine
- Indiana University
- San Antonio Community Hospital
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
MEDI-507
MEDI-507
MEDI-507
MEDI-507
MEDI-507
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00807794
Brief Title
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
November 1997 (Actual)
Study Completion Date
January 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedImmune LLC
4. Oversight
5. Study Description
Brief Summary
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Detailed Description
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MEDI-507
Arm Title
2
Arm Type
Experimental
Arm Description
MEDI-507
Arm Title
3
Arm Type
Experimental
Arm Description
MEDI-507
Arm Title
4
Arm Type
Experimental
Arm Description
MEDI-507
Arm Title
5
Arm Type
Experimental
Arm Description
MEDI-507
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
0.012 mg/kg dose given twice between 60 to 72 hours apart
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
0.06 mg/kg dose given twice between 60 to 72 hours apart
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
0.12 mg/kg dose given twice between 60 to 72 hours apart
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Bruce McClain, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
San Antonio Community Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia
City
Charlottesville,
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
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