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

To evaluate the clinical safety of different doses of MEDI-507 through day 33.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases
• Intervention / Treatment: Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507

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

Study Locations

• United States
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; MEDI-507	Drug: MEDI-507; 0.012 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.06 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.12 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental); Drug: MEDI-507; 0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Experimental: 2; MEDI-507	Drug: MEDI-507; 0.012 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.06 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.12 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental); Drug: MEDI-507; 0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Experimental: 3; MEDI-507	Drug: MEDI-507; 0.012 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.06 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.12 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental); Drug: MEDI-507; 0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Experimental: 4; MEDI-507	Drug: MEDI-507; 0.012 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.06 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.12 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental); Drug: MEDI-507; 0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
Experimental: 5; MEDI-507	Drug: MEDI-507; 0.012 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.06 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.12 mg/kg dose given twice between 60 to 72 hours apart; Drug: MEDI-507; 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental); Drug: MEDI-507; 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.	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.	Day 33

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: J. Bruce McClain, M.D., MedImmune LLC

Study record dates

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: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: MI-CP027