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

Study Overview
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Brief Summary
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To evaluate the clinical safety of different doses of MEDI-507 through day 33.

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

Official Title
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Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection

Conditions
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Kidney Diseases

Intervention / Treatment
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* Drug: MEDI-507
* Drug: MEDI-507
* Drug: MEDI-507
* Drug: MEDI-507
* Drug: MEDI-507


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |