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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00807794
First received: December 10, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: J. Bruce McClain, M.D., Medimmune Inc.
ClinicalTrials.gov Identifier: NCT00807794     History of Changes
Other Study ID Numbers: MI-CP027
Study First Received: December 10, 2008
Last Updated: December 10, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014