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

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00807794
• Collaborator: (none)
• Enrollment: 13
• Locations: 4
• Arms: 5
• Duration (Months): 11
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases	Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507	Phase 1

Detailed Description

To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• 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
• Study Start Date: Feb 1, 1997
• Actual Primary Completion Date: Nov 1, 1997
• Actual Study Completion Date: Jan 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06510
2	Indiana University	Bloomington	Indiana	United States	47405
3	San Antonio Community Hospital	San Antonio	Texas	United States	78229
4	University of Virginia	Charlottesville,	Virginia	United States	22908

Sponsors and Collaborators

• MedImmune LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00807794
• Other Study ID Numbers: MI-CP027
• First Posted: Dec 12, 2008
• Last Update Posted: Dec 12, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Dec 12, 2008