A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
1 other identifier
interventional
13
1 country
4
Brief Summary
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 1997
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 10, 2008
CompletedFirst Posted
Study publicly available on registry
December 12, 2008
CompletedDecember 12, 2008
December 1, 2008
9 months
December 10, 2008
December 10, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (5)
1
EXPERIMENTALMEDI-507
2
EXPERIMENTALMEDI-507
3
EXPERIMENTALMEDI-507
4
EXPERIMENTALMEDI-507
5
EXPERIMENTALMEDI-507
Interventions
Eligibility Criteria
You may qualify if:
- Renal allograft recipients receiving their first or second allograft
- Age over 18
- Maintained on conventional immunosuppression
- Completed informed consent document
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (4)
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Indiana University
Bloomington, Indiana, 47405, United States
San Antonio Community Hospital
San Antonio, Texas, 78229, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
J. Bruce McClain, M.D.
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2008
First Posted
December 12, 2008
Study Start
February 1, 1997
Primary Completion
November 1, 1997
Study Completion
January 1, 1998
Last Updated
December 12, 2008
Record last verified: 2008-12