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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807794
First Posted: December 12, 2008
Last Update Posted: December 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MedImmune LLC
  Purpose
To evaluate the clinical safety of different doses of MEDI-507 through day 33.

Condition Intervention Phase
Kidney Diseases Drug: MEDI-507 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by MedImmune LLC:

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. [ Time Frame: Day 33 ]

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. [ Time Frame: Day 33 ]

Enrollment: 13
Study Start Date: February 1997
Study Completion Date: January 1998
Primary Completion Date: November 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-507
Drug: MEDI-507
0.012 mg/kg dose given twice between 60 to 72 hours apart
Experimental: 2
MEDI-507
Drug: MEDI-507
0.06 mg/kg dose given twice between 60 to 72 hours apart
Experimental: 3
MEDI-507
Drug: MEDI-507
0.12 mg/kg dose given twice between 60 to 72 hours apart
Experimental: 4
MEDI-507
Drug: MEDI-507
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Experimental: 5
MEDI-507
Drug: MEDI-507
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)

Detailed Description:
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807794


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
United States, Texas
San Antonio Community Hospital
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville,, Virginia, United States, 22908
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: J. Bruce McClain, M.D. MedImmune LLC
  More Information

Responsible Party: J. Bruce McClain, M.D., Medimmune Inc.
ClinicalTrials.gov Identifier: NCT00807794     History of Changes
Other Study ID Numbers: MI-CP027
First Submitted: December 10, 2008
First Posted: December 12, 2008
Last Update Posted: December 12, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases


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