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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Kidney Diseases

Treatments: Drug: MEDI-507

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807794

MI-CP027

Details and patient eligibility

About

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

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 5 patient groups

1

Experimental group

Description:

MEDI-507

Treatment:

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

2

Experimental group

Description:

MEDI-507

Treatment:

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

3

Experimental group

Description:

MEDI-507

Treatment:

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

4

Experimental group

Description:

MEDI-507

Treatment:

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

5

Experimental group

Description:

MEDI-507

Treatment:

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507

Drug: MEDI-507