Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI-507 |
|
| 2 | Experimental | MEDI-507 |
|
| 3 | Experimental | MEDI-507 |
|
| 4 | Experimental | MEDI-507 |
|
| 5 | Experimental | MEDI-507 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-507 | Drug | 0.012 mg/kg dose given twice between 60 to 72 hours apart |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J. Bruce McClain, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| Indiana University |
Not provided
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C544394 | siplizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MEDI-507 |
| Drug |
0.06 mg/kg dose given twice between 60 to 72 hours apart |
|
| MEDI-507 | Drug | 0.12 mg/kg dose given twice between 60 to 72 hours apart |
|
| MEDI-507 | Drug | 0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental) |
|
| MEDI-507 | Drug | 0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental) |
|
| Bloomington |
| Indiana |
| 47405 |
| United States |
| San Antonio Community Hospital | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| D052801 | Male Urogenital Diseases |